Cardiac Assist, Maquet Cardiovascular, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Cardiac Assist, Maquet Cardiovascular, LLC makes
Cardiac Assist, Maquet Cardiovascular, LLC manufactures intra-aortic balloon catheters and related accessories, including the SENSATION™ PLUS 8FR 50cc device and the CARDIOSAVE Hybrid intra-aortic balloon pump. These products are designed for temporary circulatory support during cardiac procedures or acute heart failure.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cardiosave Hybrid Intra-Aortic Balloon Pump Ref K112372
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiac Assist, Maquet Cardiovascular, LLC have in the registry?
The registry currently lists 2 devices for Cardiac Assist, Maquet Cardiovascular, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Assist, Maquet Cardiovascular, LLC's devices?
Among its 2 most recently registered devices, Cardiac Assist, Maquet Cardiovascular, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Cardiac Assist, Maquet Cardiovascular, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cardiac Assist, Maquet Cardiovascular, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiac Assist, Maquet Cardiovascular, LLC in the registry?
The most recently registered devices listed for Cardiac Assist, Maquet Cardiovascular, LLC include SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES and CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP.