K021213 is an FDA 510(k) clearance for the MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS. This device is classified as a Graft, Vascular, Synthetic/biologic Composite (Class II - Special Controls, product code MAL).
Submitted by Boston Scientific Corp (Natick, US). The FDA issued a Cleared decision on April 19, 2002, 2 days after receiving the submission on April 17, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K021213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2002 |
| Decision Date | April 19, 2002 |
| Days to Decision | 2 days |
| Submission Type | Special |
| 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 |