K203307 is an FDA 510(k) clearance for the VIOLA. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Vascular Graft Solutions, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on February 17, 2021, 100 days after receiving the submission on November 9, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K203307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2020 |
| Decision Date | February 17, 2021 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |