Manufacturer's Devices - Abiomed Inc.
Address:
22 Cherry Hill Drive
Danvers
Massachusetts 01923
United States
Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:
Compass House Vision Park Histon c/o Cr360 – UL International
Cambridge
CB24 9BZ
England United Kingdom
| Code/Term |
|
Type |
| Intracardiac circulatory assist axial-pump catheter | Intracardiac circulatory assist axial-pump catheter | Class III
|
| Surgical implant template single-use | Surgical implant template single-use | Class IIa
|
| Vascular catheter introduction set nonimplantable | Vascular catheter introduction set nonimplantable | Class IIa
|
| Electrical-only medical device connection cable single-use | Electrical-only medical device connection cable single-use | Class I
|
| Cannula clamp | Cannula clamp | Class I
|
| Intracardiac circulatory assist axial-pump catheter control unit | Intracardiac circulatory assist axial-pump catheter control unit | Class IIb
|
| Cardiac/peripheral vascular guidewire single-use | Cardiac/peripheral vascular guidewire single-use | Class IIa
|
| Infusion pump cassette | Infusion pump cassette | Class IIa
|
| Catheter orifice occluder | Catheter orifice occluder | Class IIa
|
| Catheter orifice occluder | Intracardiac circulatory assist axial-pump catheter Conformity Assessment Certificate Expired |
|
| Catheter orifice occluder | Intracardiac circulatory assist axial-pump catheter Conformity Assessment Certificate Expired | Class III
|