Atheropoint, LLC
Country not established
- Devices
- 1
What Atheropoint, LLC makes
Atheropoint, LLC manufactures the ATHEROEDGE device, a diagnostic tool designed for assessing atherosclerotic plaque characteristics within coronary arteries. This device aids in identifying vulnerable plaque features to support clinical decision-making during coronary interventions.
The ATHEROEDGE device is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Atheroedge Ref K122022
510(k) 510(k)
Frequently asked questions
How many devices does Atheropoint, LLC have in the registry?
The registry currently lists 1 device for Atheropoint, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Atheropoint, LLC's devices?
Among its 1 most recently registered device, Atheropoint, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Atheropoint, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Atheropoint, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Atheropoint, LLC in the registry?
The most recently registered devices listed for Atheropoint, LLC include ATHEROEDGE.