The following data is part of a premarket notification filed by Ensite Vacular, Llc with the FDA for Siteseal Femoral Compression Device.
| Device ID | K192413 |
| 510k Number | K192413 |
| Device Name: | SiteSeal Femoral Compression Device |
| Classification | Clamp, Vascular |
| Applicant | Ensite Vacular, LLC 10900 South Clay Blair Blvd, Suite 800 Olathe, KS 66061 |
| Contact | Tom Reidy |
| Correspondent | Shree Koushik TAMM Net, Inc 1 Clearwater Court Damascus, MD 20872 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-03-31 |
| Summary: | summary |