Epicor Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Epicor Medical, Inc. makes
Epicor Medical, Inc. manufactures ablation systems and accessories designed for cardiac procedures, including the Epicor Medical Ablation System and the ULTRACINCH Ablation Device with associated accessory packs (models UC-8 through UC-14 and UC-ACC-1). These devices are intended for use in creating controlled tissue lesions to treat arrhythmias.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database. Epicor Medical, Inc. is based in the United States.
Catalogue
Epicor Medical Ablation System Ref K022894
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Epicor Medical, Inc. have in the registry?
The registry currently lists 2 devices for Epicor Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epicor Medical, Inc.'s devices?
Among its 2 most recently registered devices, Epicor Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Epicor Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Epicor Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Epicor Medical, Inc. in the registry?
The most recently registered devices listed for Epicor Medical, Inc. include EPICOR MEDICAL ABLATION SYSTEM and ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1.