Kaneka Medical America, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Kaneka Medical America, LLC makes
Kaneka Medical America, LLC manufactures the i-ED COIL System and the Thrombuster II Aspiration Catheter. These products are specialized medical devices used for interventional procedures.
The company is based in the United States, and its portfolio includes Class II medical devices. These devices are listed in the FDA 510(k) regulatory registry.
Catalogue
i-ED COIL System Ref K210638
Regimes: 510(k) Registry: 510(k)Thrombuster II Aspiration Catheter Ref K213166
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kaneka Medical America, LLC have in the registry?
The registry currently lists 2 devices for Kaneka Medical America, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kaneka Medical America, LLC's devices?
Among its 2 most recently registered devices, Kaneka Medical America, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Kaneka Medical America, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Kaneka Medical America, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kaneka Medical America, LLC in the registry?
The most recently registered devices listed for Kaneka Medical America, LLC include i-ED COIL System and Thrombuster II Aspiration Catheter.