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 catheterIntracardiac circulatory assist axial-pump catheterClass III
Intracardiac circulatory assist axial-pump catheterIntracardiac circulatory assist axial-pump catheterClass III
Surgical implant template single-useSurgical implant template single-useClass IIa
Vascular catheter introduction set nonimplantableVascular catheter introduction set nonimplantableClass IIa
Electrical-only medical device connection cable single-useElectrical-only medical device connection cable single-useClass I
Cannula clampCannula clampClass I
Intracardiac circulatory assist axial-pump catheter control unitIntracardiac circulatory assist axial-pump catheter control unitClass IIb
Cardiac/peripheral vascular guidewire single-useCardiac/peripheral vascular guidewire single-useClass IIa
Infusion pump cassetteInfusion pump cassetteClass IIa
Catheter orifice occluderCatheter orifice occluderClass IIa
Intracardiac circulatory assist axial-pump catheterIntracardiac circulatory assist axial-pump catheter