Cardiomedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Cardiomedics, Inc. makes
Cardiomedics, Inc. manufactures external counterpulsation systems, including the CardiaSSIST Counterpulsation System Series 4000/5000 and the CardioMedics ECP System. These devices are designed to augment blood flow in the coronary arteries by inflating and deflating external cuffs around the legs in synchrony with the heart’s cycle, intended for patients with angina or other circulatory conditions.
The company’s portfolio consists of Class II devices, all of which are authorised via the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cardiomedics Ecp System Ref K010261
Regimes: 510(k) Registry: 510(k)Cardiomedics External Counterpulsation System Ref K872034
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiomedics, Inc. have in the registry?
The registry currently lists 5 devices for Cardiomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiomedics, Inc.'s devices?
Among its 5 most recently registered devices, Cardiomedics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cardiomedics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cardiomedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiomedics, Inc. in the registry?
The most recently registered devices listed for Cardiomedics, Inc. include CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000, CARDIOMEDICS ECP SYSTEM, CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM and CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000.