Evalve, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Evalve, Inc. makes
Evalve, Inc. manufactures steerable guide catheters, including the Evalve Steerable Guide Catheter (Model SGC01ST) and its modifications. These devices are designed for precise vascular access and navigation during interventional procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. The devices are listed in the FDA’s 510(k) registry, reflecting their compliance with US regulatory requirements.
Catalogue
Steerable Guide Catheter Ref K083793
510(k) 510(k)- 510(k) 510(k)
Evalve Steerable Guide Catheter, Model SGC01ST Ref K091596
510(k) 510(k)Evalve Steerable Guide Catheter Ref K093866
510(k) 510(k)
Frequently asked questions
How many devices does Evalve, Inc. have in the registry?
The registry currently lists 4 devices for Evalve, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Evalve, Inc.'s devices?
Among its 4 most recently registered devices, Evalve, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Evalve, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Evalve, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Evalve, Inc. in the registry?
The most recently registered devices listed for Evalve, Inc. include STEERABLE GUIDE CATHETER, MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST, EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST and EVALVE STEERABLE GUIDE CATHETER.