K190351 is an FDA 510(k) clearance for the Site Seal SV. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Ensite Vascular (Olathe, US). The FDA issued a Cleared decision on July 2, 2019, 138 days after receiving the submission on February 14, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K190351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2019 |
| Decision Date | July 02, 2019 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXC - Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |