Manufacturer's Devices - Boston Scientific Corporation

Address:




300 Boston Scientific Way



Marlborough

Massachusetts 01752

United States


Authorised Representative/ UK Responsible Person
Name: Boston Scientific Limited
Address:

100 New Bridge Street



London

EC4V 6JA

England United Kingdom




Code/Term Type
Peripheral artery stent bare-metalPeripheral artery stent bare-metalClass III
Drug-eluting coronary artery stent non-bioabsorbable-polymer-coatedDrug-eluting coronary artery stent non-bioabsorbable-polymer-coatedClass III
Drug-eluting coronary artery stent bioabsorbable-polymer-coatedDrug-eluting coronary artery stent bioabsorbable-polymer-coatedClass III
Pelvic organ prolapse surgical mesh synthetic polymerPelvic organ prolapse surgical mesh synthetic polymerClass IIb
Drug-eluting infrapopliteal artery stent non-bioabsorbableDrug-eluting infrapopliteal artery stent non-bioabsorbableClass III
Bare-metal oesophageal stent non-sterileBare-metal oesophageal stent non-sterileClass IIb
Polymer-metal tracheal/bronchial stentPolymer-metal tracheal/bronchial stentClass IIb
Bare-metal tracheal/bronchial stent non-sterileBare-metal tracheal/bronchial stent non-sterileClass IIb
Gastrojejunostomy tubeGastrojejunostomy tubeClass IIb
Intravascular occluding balloon catheter image-guidedIntravascular occluding balloon catheter image-guidedClass III
Bare-metal duodenal stentBare-metal duodenal stentClass IIb
Drug-eluting peripheral artery stent bare-metalDrug-eluting peripheral artery stent bare-metalClass III
Bare-metal carotid artery stentBare-metal carotid artery stentClass III
Cardiac occluder delivery kitCardiac occluder delivery kitClass III
Cardiac defect occluderCardiac defect occluderClass III
Embolic protection filtering guidewireEmbolic protection filtering guidewireClass III
Coronary angioplasty balloon catheter cutting/scoringCoronary angioplasty balloon catheter cutting/scoringClass III
Polymeric biliary stent non-bioabsorbablePolymeric biliary stent non-bioabsorbableClass IIb
Bare-metal colonic stentBare-metal colonic stentClass IIb
Gastrostomy tubeGastrostomy tubeClass IIb
Coronary angioplasty balloon catheter basicCoronary angioplasty balloon catheter basicClass III
Mechanical atherectomy system coronary battery-poweredMechanical atherectomy system coronary battery-poweredClass III
Ligation clip metallicLigation clip metallicClass IIb
Cardiovascular ultrasound imaging systemCardiovascular ultrasound imaging systemClass III
Polymeric pancreatic stent non-bioabsorbablePolymeric pancreatic stent non-bioabsorbableClass IIb
Intravascular ultrasound imaging catheter single-useIntravascular ultrasound imaging catheter single-useClass III
Vascular microcatheterVascular microcatheterClass III
Intravascular haemodynamic monitoring system guidewireIntravascular haemodynamic monitoring system guidewireClass III
Cardiac radio-frequency ablation system catheterCardiac radio-frequency ablation system catheterClass III
Polymer-metal oesophageal stent non-sterilePolymer-metal oesophageal stent non-sterileClass IIb
Polymeric ureteral stentPolymeric ureteral stentClass IIb
Bare-metal coronary artery stentBare-metal coronary artery stentClass III
Female stress urinary incontinence surgical mesh-sling synthetic polymerFemale stress urinary incontinence surgical mesh-sling synthetic polymerClass IIb
Urethral sphincter prosthesis non-poweredUrethral sphincter prosthesis non-poweredClass IIb
Urethral sphincter prosthesis non-poweredUrethral sphincter prosthesis non-poweredClass IIb
Rigid penile prosthesisRigid penile prosthesisClass IIb
Aortic transcatheter heart valve bioprosthesis stent-like frameworkAortic transcatheter heart valve bioprosthesis stent-like frameworkClass III
Aortic transcatheter heart valve bioprosthesis stent-like frameworkAortic transcatheter heart valve bioprosthesis stent-like frameworkClass III
Gastrostomy tube kit non-medicatedGastrostomy tube kit non-medicatedClass IIb
Gastrostomy tube kit non-medicatedGastrostomy tube kit non-medicatedClass IIb
Bare-metal biliary stentBare-metal biliary stentClass IIb
Inflatable penile prosthesisInflatable penile prosthesisClass IIb
Vascular guide-catheter single-useVascular guide-catheter single-useClass III
Biliary drainBiliary drain
Nephrostomy catheterNephrostomy catheter
Aspiration tray single-useAspiration tray single-use
Polymeric pancreatic stent non-bioabsorbablePolymeric pancreatic stent non-bioabsorbable
Polymeric biliary stent non-bioabsorbablePolymeric biliary stent non-bioabsorbable
Gastrojejunostomy tubeGastrojejunostomy tube
Pelvic organ prolapse surgical mesh synthetic polymerPelvic organ prolapse surgical mesh synthetic polymer
Gastrostomy tube kit non-medicatedGastrostomy tube kit non-medicated
Embolization particle non-bioabsorbableEmbolization particle non-bioabsorbableClass III
Vascular microcatheterVascular microcatheterClass III
Nephrostomy catheterNephrostomy catheterClass IIb
Non-neurovascular embolization coilNon-neurovascular embolization coilClass IIb
Polymer-metal biliary stent non-bioabsorbablePolymer-metal biliary stent non-bioabsorbableClass IIb
Bare-metal biliary stentBare-metal biliary stentClass IIb
Urethral sphincter prosthesis non-poweredUrethral sphincter prosthesis non-poweredClass IIb
Pleural catheterPleural catheterClass IIb
Iliac artery endovascular stent-graftIliac artery endovascular stent-graftClass IIb
Iliac artery stent bare-metalIliac artery stent bare-metalClass IIb
Vascular microcatheterVascular microcatheterClass IIa
Vascular microcatheterVascular microcatheterClass IIb
Biliary drainBiliary drainClass IIa
Biliary drainBiliary drainClass IIa
Nephrostomy catheterNephrostomy catheterClass IIa
Nephrostomy catheterNephrostomy catheterClass IIb
Urethral dilator reusableUrethral dilator reusableClass IIa
Electrosurgical system generatorElectrosurgical system generatorClass IIb
Urological catheter stylet transurethralUrological catheter stylet transurethralClass IIa
Urological irrigation setUrological irrigation setClass IIa
Peripheral angioplasty balloon catheter basicPeripheral angioplasty balloon catheter basicClass IIa
Peripheral angioplasty balloon catheter basicPeripheral angioplasty balloon catheter basicClass IIa
Mechanical atherectomy system coronary battery-poweredMechanical atherectomy system coronary battery-poweredClass IIa
Mechanical atherectomy system coronary battery-poweredMechanical atherectomy system coronary battery-poweredClass IIb
Catheter/overtube balloon inflator single-useCatheter/overtube balloon inflator single-useClass IIa
Vascular guide-catheter single-useVascular guide-catheter single-useClass IIa
Urethral dilatation catheter non-medicatedUrethral dilatation catheter non-medicatedClass IIa
Intravascular occluding balloon catheter image-guidedIntravascular occluding balloon catheter image-guidedClass IIb
Ureteral catheterUreteral catheterClass IIa
Percutaneous radio-frequency ablation system generatorPercutaneous radio-frequency ablation system generatorClass IIb
StopcockStopcockClass IIa
Body aspiration needle single-useBody aspiration needle single-useClass IIa
General/multiple surgical solid-state laser systemGeneral/multiple surgical solid-state laser systemClass IIb
Flexible video choledochoscopeFlexible video choledochoscopeClass IIa
Basic roller pumpBasic roller pumpClass IIb
Flexible endoscopic biopsy forceps single-useFlexible endoscopic biopsy forceps single-useClass IIa
Flexible endoscopic biopsy forceps single-useFlexible endoscopic biopsy forceps single-useClass IIb
Flexible endoscopic biopsy forceps single-useFlexible endoscopic biopsy forceps single-useClass IIa
Endoscopic-access dilator single-useEndoscopic-access dilator single-useClass IIa
General-purpose endoscopic needle single-useGeneral-purpose endoscopic needle single-useClass IIa
Cardiovascular ultrasound imaging systemCardiovascular ultrasound imaging systemClass IIa
Polymeric pancreatic stent non-bioabsorbablePolymeric pancreatic stent non-bioabsorbableClass IIb
Polymeric biliary stent non-bioabsorbablePolymeric biliary stent non-bioabsorbableClass IIb
Embolization implant inserterEmbolization implant inserterClass IIa
Foot-switch electricalFoot-switch electricalClass IIb
Mechanical atherectomy system catheter peripheralMechanical atherectomy system catheter peripheralClass IIb
Urinary stone retrieval basket single-useUrinary stone retrieval basket single-useClass IIa
Biliary/urinary stone retrieval basket single-useBiliary/urinary stone retrieval basket single-useClass IIa
Cardiac ablation system irrigation tubing setCardiac ablation system irrigation tubing setClass IIa
Gastrointestinal/biliary dilation balloon catheterGastrointestinal/biliary dilation balloon catheterClass IIa
Transducer signal amplifierTransducer signal amplifierClass IIa
Cardiac mapping systemCardiac mapping systemClass IIa
Cardiac mapping systemCardiac mapping systemClass IIa
Gastrointestinal/airway foreign body retrieval basket single-useGastrointestinal/airway foreign body retrieval basket single-useClass IIa
ERCP catheter non-balloon non-electrical reusableERCP catheter non-balloon non-electrical reusableClass IIa
Oesophageal endoscopic ligator single-useOesophageal endoscopic ligator single-useClass IIa
Gastro-urological guidewire single-useGastro-urological guidewire single-useClass IIa
Ureteropelvic balloon catheterUreteropelvic balloon catheterClass IIa
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass IIa
Urogenital surgical laser system beam guide single-useUrogenital surgical laser system beam guide single-useClass IIa
Multi-purpose percutaneous abdominothoracic drainage catheterMulti-purpose percutaneous abdominothoracic drainage catheterClass IIa
Suturing unit single-useSuturing unit single-useClass IIa
Suturing unit single-useSuturing unit single-useClass IIa
Endoscopic electrosurgical handpiece/electrode bipolar single-useEndoscopic electrosurgical handpiece/electrode bipolar single-useClass IIb
Radio-frequency ablation systemRadio-frequency ablation systemClass IIb
Endoscopic electrosurgical handpiece/electrode monopolar single-useEndoscopic electrosurgical handpiece/electrode monopolar single-useClass IIa
Endoscopic electrosurgical handpiece/electrode monopolar single-useEndoscopic electrosurgical handpiece/electrode monopolar single-useClass IIa
Peripheral vascular guidewire manualPeripheral vascular guidewire manualClass IIa
Thrombectomy suction catheterThrombectomy suction catheterClass IIa
Thrombectomy suction catheterThrombectomy suction catheterClass IIb
Percutaneous radio-frequency ablation system probe cannula single-usePercutaneous radio-frequency ablation system probe cannula single-useClass IIb
Vascular catheter introduction set nonimplantableVascular catheter introduction set nonimplantableClass IIa
Endoscope working-channel sealEndoscope working-channel sealClass IIa
Cardiac cryosurgical systemCardiac cryosurgical systemClass IIb
Endoscopic insufflation tubing set single-useEndoscopic insufflation tubing set single-useClass IIa
Mechanical atherectomy system coronary line-poweredMechanical atherectomy system coronary line-poweredClass IIa
General/multiple surgical laser system beam guide reusableGeneral/multiple surgical laser system beam guide reusableClass IIa
Nephrostomy catheter introduction needleNephrostomy catheter introduction needleClass IIa
Endoscopic electrosurgical mucosal biopsy/resection setEndoscopic electrosurgical mucosal biopsy/resection setClass IIa
Endoscopic electrosurgical electrode monopolar single-useEndoscopic electrosurgical electrode monopolar single-useClass IIa
Percutaneous radio-frequency ablation probe tumour-ablation monopolarPercutaneous radio-frequency ablation probe tumour-ablation monopolarClass IIb
Submucosal lift solutionSubmucosal lift solutionClass IIa
Submucosal lift solutionSubmucosal lift solutionClass IIa
Enteral tube extension non-sterileEnteral tube extension non-sterileClass IIb
General/multiple surgical laser system beam guide single-useGeneral/multiple surgical laser system beam guide single-useClass IIa
Mechanical-cutting endoscopic polypectomy snareMechanical-cutting endoscopic polypectomy snareClass IIa
Corpus cavernosum dilator single-useCorpus cavernosum dilator single-useClass IIa
Flexible video choledochoscope single-useFlexible video choledochoscope single-useClass IIa
Flexible video ureteroscope single-useFlexible video ureteroscope single-useClass IIa
Flexible video ureteroscope single-useFlexible video ureteroscope single-useClass IIa
Gastrostomy tube kit non-medicatedGastrostomy tube kit non-medicatedClass IIb
Luer/non-ISO80369-standardized small-bore multichannel connectorLuer/non-ISO80369-standardized small-bore multichannel connectorClass IIb
Thrombectomy tubing set non-electronicThrombectomy tubing set non-electronicClass IIa
Intravascular ultrasound imaging catheter single-useIntravascular ultrasound imaging catheter single-useClass IIa
Inflatable penile prosthesisInflatable penile prosthesisClass III
Vena cava filter temporary/permanentVena cava filter temporary/permanentClass III
Multiple physiological signal amplifierMultiple physiological signal amplifierClass IIb
Cardiac mapping catheter percutaneous single-useCardiac mapping catheter percutaneous single-useClass III
Angiographic catheter single-useAngiographic catheter single-useClass III
Vascular guide-catheter single-useVascular guide-catheter single-useClass III
Biliary drainBiliary drainClass IIb
Nephrostomy catheterNephrostomy catheterClass IIa
General-purpose multi-parameter bedside monitorGeneral-purpose multi-parameter bedside monitorClass IIb
Mechanical atherectomy/thrombectomy drive systemMechanical atherectomy/thrombectomy drive systemClass IIb
Radiotherapy protection spacerRadiotherapy protection spacerClass III
Endoscopic guidewire holderEndoscopic guidewire holderClass I
Endoscopic suction valve single-use sterileEndoscopic suction valve single-use sterileClass I
Wearable percutaneous catheter/tube holderWearable percutaneous catheter/tube holderClass I
Coronary artery guidewire extensionCoronary artery guidewire extensionClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Electrical-only medical device connection cable single-useElectrical-only medical device connection cable single-useClass I
Electrical-only medical device connection cable single-useElectrical-only medical device connection cable single-useClass I
ERCP catheter balloon non-electrical stone-retrievalERCP catheter balloon non-electrical stone-retrievalClass I
Catheter/overtube balloon inflator reusableCatheter/overtube balloon inflator reusableClass I
Catheter/overtube balloon inflator reusableCatheter/overtube balloon inflator reusableClass I
Catheter-exchange guidewire holderCatheter-exchange guidewire holderClass I
Medical device cleaning sponge/setMedical device cleaning sponge/setClass I
Endoscopic biopsy valve single-useEndoscopic biopsy valve single-useClass I
Endoscope flushing adaptor single-useEndoscope flushing adaptor single-useClass I
Vascular catheter introduction needleVascular catheter introduction needleClass IIa
Cardiac cryosurgical system catheterCardiac cryosurgical system catheterClass III
Cardiac ablation thoracic motion sensorCardiac ablation thoracic motion sensorClass IIa
Radio-frequency ablation systemRadio-frequency ablation systemClass IIb
Intracardiac catheter-tip electrodeIntracardiac catheter-tip electrodeClass III
Manual biliary stone fragmenterManual biliary stone fragmenterClass IIa
Electrical-only medical device connection cable single-useElectrical-only medical device connection cable single-useClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Cholangiography tubing setCholangiography tubing setClass I
Instrument hygienic-transportation bagInstrument hygienic-transportation bagClass I
Endoscopic biopsy valve single-useEndoscopic biopsy valve single-useClass I
Gastro-urological directorGastro-urological directorClass I
Torque manipulation deviceTorque manipulation deviceClass I
Isolation gown single-useIsolation gown single-useClass I
Surgical suction system collection container single-useSurgical suction system collection container single-useClass I
Endoscopic video image processing/light source systemEndoscopic video image processing/light source systemClass I
Endoscopic video image processing/light source systemEndoscopic video image processing/light source systemClass I
Endoscopic bite block basic single-useEndoscopic bite block basic single-useClass I
Intravascular catheter slitterIntravascular catheter slitterClass I
Wire/ligature passer reusableWire/ligature passer reusableClass I
Bronchial balloon catheterBronchial balloon catheterClass I
Catheter/overtube balloon inflator single-useCatheter/overtube balloon inflator single-useClass I
Suction/irrigation tubing single-useSuction/irrigation tubing single-useClass I
ERCP catheter non-balloon non-electrical single-useERCP catheter non-balloon non-electrical single-useClass I
Medical equipment drape single-useMedical equipment drape single-useClass I
Nephrostomy catheterNephrostomy catheterClass I
Electrocardiographic lead set reusableElectrocardiographic lead set reusableClass I
Electrocardiographic lead set reusableElectrocardiographic lead set reusableClass I
Aspiration tray single-useAspiration tray single-useClass I
Gastrointestinal/airway foreign body retrieval basket single-useGastrointestinal/airway foreign body retrieval basket single-useClass I
Cardiac mapping system reference patchCardiac mapping system reference patchClass I
Gastrointestinal/biliary dilation balloon catheterGastrointestinal/biliary dilation balloon catheterClass I
Medical ruler reusableMedical ruler reusableClass I
Low-pressure tubing connector reusableLow-pressure tubing connector reusableClass I
Cardiovascular ultrasound imaging systemCardiovascular ultrasound imaging systemClass I
Surgical instrument/endoscope cleaning utensil single-useSurgical instrument/endoscope cleaning utensil single-useClass I
Flexible endoscopic cytology brush single-useFlexible endoscopic cytology brush single-useClass I
Electronic signal frequency filterElectronic signal frequency filterClass I
Foot-switch electricalFoot-switch electricalClass I
Foot-switch electricalFoot-switch electricalClass I
Foot-switch electricalFoot-switch electricalClass I
Foot-switch electricalFoot-switch electricalClass I
Laser filter opticalLaser filter opticalClass I
Catheter flush syringe connectorCatheter flush syringe connectorClass I
Embolization particle non-bioabsorbableEmbolization particle non-bioabsorbableClass IIb
Embolization particle non-bioabsorbableEmbolization particle non-bioabsorbableClass IIb
Peripheral artery stent bare-metalPeripheral artery stent bare-metalClass IIb
Intracardiac catheter-tip electrodeIntracardiac catheter-tip electrodeClass III
Imaging lesion localization marker implantableImaging lesion localization marker implantableClass IIb
Cardiac mapping catheter percutaneous single-useCardiac mapping catheter percutaneous single-useClass III
Endoscope channel support kitEndoscope channel support kitClass I
Peripheral angioplasty balloon catheter basicPeripheral angioplasty balloon catheter basicClass III
Implantable transenteric drainage tubeImplantable transenteric drainage tubeClass IIb
Electrosurgical cable adaptorElectrosurgical cable adaptorClass I
Electrosurgical cable adaptorElectrosurgical cable adaptorClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Continuous electronic patient thermometer line-poweredContinuous electronic patient thermometer line-poweredClass I
Cardiac cryosurgical system remote controlCardiac cryosurgical system remote controlClass IIb
Continuous electronic patient thermometer line-poweredContinuous electronic patient thermometer line-poweredClass I
Ureteral stent-placement setUreteral stent-placement set
Urethral dilatation catheter non-medicatedUrethral dilatation catheter non-medicated
Submucosal lift solutionSubmucosal lift solution
Nephrostomy catheterNephrostomy catheter
Interventional radiology percutaneous-access procedure kitInterventional radiology percutaneous-access procedure kit
Male stress urinary incontinence surgical mesh-sling synthetic polymerMale stress urinary incontinence surgical mesh-sling synthetic polymer
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Ureteral stent-placement setUreteral stent-placement set
Thrombectomy suction catheterThrombectomy suction catheter Conformity Assessment Certificate ExpiredClass III
Fascial tissue dilator single-useFascial tissue dilator single-useClass I
Ultrasound thrombolysis system catheter peripheralUltrasound thrombolysis system catheter peripheralClass III
Cardiac/peripheral vascular guidewire single-useCardiac/peripheral vascular guidewire single-useClass IIa
Cardiac/peripheral vascular guidewire single-useCardiac/peripheral vascular guidewire single-useClass III
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Polymer-metal oesophageal stent sterilePolymer-metal oesophageal stent sterileClass IIb
ERCP catheter non-balloon electrosurgicalERCP catheter non-balloon electrosurgicalClass IIa
Endoscopic video image processing unitEndoscopic video image processing unitClass I
Endoscopic insufflation tubing set reusableEndoscopic insufflation tubing set reusableClass IIa
Surgical irrigation tubing set reusableSurgical irrigation tubing set reusableClass IIa
Endoscopic video image display monitorEndoscopic video image display monitorClass I
Flexible video bronchoscope single-useFlexible video bronchoscope single-useClass IIa
Flexible video duodenoscope single-useFlexible video duodenoscope single-useClass IIa
Endoscopic guidewire holderEndoscopic guidewire holderClass I
Chemotherapeutic agent embolization particleChemotherapeutic agent embolization particleClass III
Endoscopy preparation kitEndoscopy preparation kit
Inflatable penile prosthesisInflatable penile prosthesisClass IIb