Cardiomedical GmbH
Country not established
- Devices
- 1
What Cardiomedical GmbH makes
Cardiomedical GmbH manufactures MICS aortic clamps, a type of minimally invasive surgical instrument used for precise clamping of the aorta during cardiac procedures. These clamps are designed for use in minimally invasive cardiac surgery (MICS) to stabilize the aorta while allowing surgeons to perform interventions with reduced invasiveness.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices, indicating moderate risk and requiring pre-market submission for safety and performance validation. The devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Cardio Vision Mics Aortic Clamps Ref K123571
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiomedical GmbH have in the registry?
The registry currently lists 1 device for Cardiomedical GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiomedical GmbH's devices?
Among its 1 most recently registered device, Cardiomedical GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Cardiomedical GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Cardiomedical GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiomedical GmbH in the registry?
The most recently registered devices listed for Cardiomedical GmbH include CARDIO VISION MICS AORTIC CLAMPS.