K093231 is an FDA 510(k) clearance for the ALBOGRAFT VASCULAR PROSTHESIS. This device is classified as a Graft, Vascular, Synthetic/biologic Composite (Class II - Special Controls, product code MAL).
Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on January 14, 2010, 92 days after receiving the submission on October 14, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K093231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2009 |
| Decision Date | January 14, 2010 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MAL — Graft, Vascular, Synthetic/biologic Composite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |