Atheromed, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Atheromed, Inc. makes
Atheromed, Inc. manufactures atherectomy catheters designed for the removal of atherosclerotic plaque within coronary and peripheral arteries. The product line includes 1.8 mm and 2.2 mm atherectomy catheters, tracking catheters (5F and 6F), and a deflecting atherectomy catheter (7D), alongside accessories like a dedicated handle and wire support clip.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
Frequently asked questions
How many devices does Atheromed, Inc. have in the registry?
The registry currently lists 2 devices for Atheromed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Atheromed, Inc.'s devices?
Among its 2 most recently registered devices, Atheromed, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Atheromed, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Atheromed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Atheromed, Inc. in the registry?
The most recently registered devices listed for Atheromed, Inc. include 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP and PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA.