Data / Medical devices / United States / Ensitevascular, LLC
Ensitevascular, LLC: FDA-registered device maker in Overland Park, KS, United States, 1 510(k) clearance
Ensitevascular, LLC is registered with the FDA (registration 3020031299) in Overland Park, KS, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 31, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020031299
- Address
- 10561 Barkley St Ste 610, Overland Park, KS, United States, 66212
- Owner or operator
- EnsiteVascular, LLC (10082533)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 10, 2021
- Registered through
- 2026
- Brand names listed
- SiteSeal 01
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Vascular | DXC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 31, 2020 | K192413 | SiteSeal Femoral Compression Device | DXC | Substantially Equivalent | Ensite Vacular, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 31, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.