Percu Surge, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Percu Surge, Inc. makes
Percu Surge, Inc. manufactures intravascular occlusion and aspiration devices, including the PercuSurge Guardwire Temporary Occlusion and Aspiration System and the Temporary Occlusion Balloon System. These products are designed for use in percutaneous coronary interventions to isolate coronary arteries and facilitate thrombus removal or plaque modification during procedures.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Temporary Occlusion Balloon System Ref K972777
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Percu Surge, Inc. have in the registry?
The registry currently lists 2 devices for Percu Surge, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Percu Surge, Inc.'s devices?
Among its 2 most recently registered devices, Percu Surge, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Percu Surge, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Percu Surge, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Percu Surge, Inc. in the registry?
The most recently registered devices listed for Percu Surge, Inc. include PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM and TEMPORARY OCCLUSION BALLOON SYSTEM.