New Aera, Inc.
Country not established
- Devices
- 1
What New Aera, Inc. makes
New Aera, Inc. manufactures the TAV System, a transcatheter aortic valve (TAV) replacement designed for percutaneous implantation in patients with aortic stenosis.
The TAV System is classified as a Class II medical device in the US and is authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
TAV System Ref K152664
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does New Aera, Inc. have in the registry?
The registry currently lists 1 device for New Aera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Aera, Inc.'s devices?
Among its 1 most recently registered device, New Aera, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do New Aera, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for New Aera, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from New Aera, Inc. in the registry?
The most recently registered devices listed for New Aera, Inc. include TAV System.