K122612 is an FDA 510(k) clearance for the HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX. This device is classified as a Graft, Vascular, Synthetic/biologic Composite (Class II - Special Controls, product code MAL).
Submitted by Maquet Cardiovascular, LLC (Wayne, US). The FDA issued a Cleared decision on September 10, 2012, 14 days after receiving the submission on August 27, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K122612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2012 |
| Decision Date | September 10, 2012 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MAL — Graft, Vascular, Synthetic/biologic Composite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |