Sulzer Carbomedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Sulzer Carbomedics, Inc. makes
The company manufactures mitral valve repair systems, including the Annuloflex Annuloplasty System (Model AF800) and the Annuloflo System (Mitral Model AR700), as well as low-profile mitral valve rotators. It produces vascular prostheses, such as the GelSoft ERS and GelWeave Valsalva vascular prostheses, and pericardial patches made from PETP, PTFE, and polypropylene. Additional products include intracardiac patches and pledgets for surgical use.
These devices are classified under FDA categories Class I and Class II, with regulatory clearance supported by 510(k) submissions. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Annuloflex Annuloplasty System, Model AF800 Ref K992056
Regimes: 510(k) Registry: 510(k)Sulzer Vascutek Gelsoft Ers Vascular Prosthesis Ref K002007
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sulzer Carbomedics Cardiofix Pericardium Ref K993288
Regimes: 510(k) Registry: 510(k)Annuloflo System, Mitral Model AR700 Ref K021051
Regimes: 510(k) Registry: 510(k)Sulzer Carbomedics Low Profile Mitral Rotator Ref K974648
Regimes: 510(k) Registry: 510(k)Annuloflex Annuoplasty System, Model Af 800 Ref K023185
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sulzer Carbomedics, Inc. have in the registry?
The registry currently lists 8 devices for Sulzer Carbomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sulzer Carbomedics, Inc.'s devices?
Among its 8 most recently registered devices, Sulzer Carbomedics, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Sulzer Carbomedics, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Sulzer Carbomedics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sulzer Carbomedics, Inc. in the registry?
The most recently registered devices listed for Sulzer Carbomedics, Inc. include ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800, SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS, SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS and SULZER CARBOMEDICS CARDIOFIX PERICARDIUM.