Ensite Vascular
Country not established
- Devices
- 2
What Ensite Vascular makes
Ensite Vascular manufactures vascular closure devices, including the SiteSeal SV and Site Seal SV, designed to seal puncture sites in blood vessels during procedures like angiography or PCI to reduce bleeding and improve patient recovery.
These devices are classified as Class II under US regulations and are listed via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
SiteSeal SV Ref K210681
Regimes: 510(k) Registry: 510(k)Site Seal SV Ref K190351
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ensite Vascular have in the registry?
The registry currently lists 2 devices for Ensite Vascular. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ensite Vascular's devices?
Among its 2 most recently registered devices, Ensite Vascular has devices listed in FDA 510(k) (2 devices).
What risk classes do Ensite Vascular's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ensite Vascular's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ensite Vascular in the registry?
The most recently registered devices listed for Ensite Vascular include SiteSeal SV and Site Seal SV.