The following data is part of a premarket notification filed by Ensite Vascular with the FDA for Site Seal Sv.
| Device ID | K190351 |
| 510k Number | K190351 |
| Device Name: | Site Seal SV |
| Classification | Clamp, Vascular |
| Applicant | Ensite Vascular 10900 S. Clay Blair Blvd. Ste 800 Olathe, KS 66061 |
| Contact | Thomas Reidy |
| Correspondent | F. Blix Winston Tamm Net Inc 2600 Mullinix Road Mt. Airy, MD 21771 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-07-02 |