Manufacturer's Devices - BIOSENSE WEBSTER INC.

Address:




31 TECHNOLOGY DRIVE SUITE 200



IRVINE

CALIFORNIA 92618

United States


Authorised Representative/ UK Responsible Person
Name: Johnson & Johnson Medical Ltd
Address:

Baird House 4 Lower Gilmore Bank



Edinburgh

EH3 9QP

Scotland United Kingdom




Code/Term Type
Intracardiac ultrasound imaging catheter steerable single-useIntracardiac ultrasound imaging catheter steerable single-useClass III
Cardiac mapping/endocardial-injection catheterCardiac mapping/endocardial-injection catheterClass III
Vascular catheter introduction set nonimplantableVascular catheter introduction set nonimplantableClass III
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass IIb
Percutaneous radio-frequency ablation system generatorPercutaneous radio-frequency ablation system generatorClass IIb
Cardiac ablation system irrigation tubing setCardiac ablation system irrigation tubing setClass IIa
Cardiac radio-frequency ablation system generatorCardiac radio-frequency ablation system generatorClass IIb
Surgical irrigation pumpSurgical irrigation pumpClass IIa
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Cardiac mapping catheter percutaneous single-useCardiac mapping catheter percutaneous single-use Conformity Assessment Certificate ExpiredClass III
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusable Conformity Assessment Certificate ExpiredClass III
Cardiac radio-frequency ablation system catheterCardiac radio-frequency ablation system catheter Conformity Assessment Certificate ExpiredClass III
Cardiac mapping catheter percutaneous single-useCardiac mapping catheter percutaneous single-useClass III
Cardiac radio-frequency ablation system catheterCardiac radio-frequency ablation system catheterClass III
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I