The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for Hemashield Woven Double Velour Vascular Graft Model M00202175xxxxx; M00202166xxxxx.
| Device ID | K122612 |
| 510k Number | K122612 |
| Device Name: | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX |
| Classification | Graft, Vascular, Synthetic/biologic Composite |
| Applicant | MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Marylou Insinga |
| Correspondent | Marylou Insinga MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | MAL |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-27 |
| Decision Date | 2012-09-10 |
| Summary: | summary |