Entac Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Entac Medical, Inc. makes
Entac Medical, Inc. manufactures the PrevisEA Device, a medical device designed for electroanatomical mapping and catheter ablation procedures in cardiac electrophysiology.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. The devices are listed in the FDA’s 510(k) registry. Entac Medical, Inc. is based in the United States.
Catalogue
PrevisEA Device Ref K211068
Regimes: 510(k) Registry: 510(k)PrevisEA Device Ref K230769
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Entac Medical, Inc. have in the registry?
The registry currently lists 2 devices for Entac Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entac Medical, Inc.'s devices?
Among its 2 most recently registered devices, Entac Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Entac Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Entac Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entac Medical, Inc. in the registry?
The most recently registered devices listed for Entac Medical, Inc. include PrevisEA Device.