Panels › Cardiovascular › Product code MAL · Class 2
Graft, Vascular, Synthetic/Biologic Composite
Regulation 870.3450
0510(k)s in 12 months (6 all time)
0recalls in 12 months (49 all time)
46recalls that name a 510(k)
Top companies in MAL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2012 | K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX Maquet Cardiovascular, LLC | MAL |
| Jan 19, 2011 | K103080 | ALBOGRAFT VASCULAR PROSTHESIS LeMaitre Vascular, Inc. | MAL |
| Jan 14, 2010 | K093231 | ALBOGRAFT VASCULAR PROSTHESIS LeMaitre Vascular, Inc. | MAL |
| Sep 12, 2005 | K052302 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION Boston Scientific Corp | MAL |
| Apr 19, 2002 | K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS Boston Scientific Corp | MAL |
| Feb 1, 1996 | K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | MAL |
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