K052302 is an FDA 510(k) clearance for the HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION. This device is classified as a Graft, Vascular, Synthetic/biologic Composite (Class II - Special Controls, product code MAL).
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on September 12, 2005, 19 days after receiving the submission on August 24, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K052302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2005 |
| Decision Date | September 12, 2005 |
| Days to Decision | 19 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 |