K230248 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 28, 2023, 29 days after receiving the submission on January 30, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K230248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2023 |
| Decision Date | February 28, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC - Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |