Endophys, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Endophys, Inc. makes
Endophys, Inc. manufactures pressure sensing sheath kits and blood pressure monitoring devices designed for clinical use, focusing on real-time intravascular pressure measurement and hemodynamic assessment.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Endophys Pressure Sensing Sheath Kit Ref K160272
Regimes: 510(k) Registry: 510(k)Endophys Pressure Sensing Sheath Kit Ref K141275
Regimes: 510(k) Registry: 510(k)Endophys Blood Pressure Monitor Ref K141615
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Endophys, Inc. have in the registry?
The registry currently lists 3 devices for Endophys, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Endophys, Inc.'s devices?
Among its 3 most recently registered devices, Endophys, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Endophys, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Endophys, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Endophys, Inc. in the registry?
The most recently registered devices listed for Endophys, Inc. include Endophys Pressure Sensing Sheath Kit and ENDOPHYS BLOOD PRESSURE MONITOR.