K954848 is an FDA 510(k) clearance for the HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT. This device is classified as a Graft, Vascular, Synthetic/biologic Composite (Class II - Special Controls, product code MAL).
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on February 1, 1996, 101 days after receiving the submission on October 23, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K954848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | October 23, 1995 |
| Decision Date | February 01, 1996 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | MAL — Graft, Vascular, Synthetic/biologic Composite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |