The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Hemashield Microvel Velour Knitted Vascular Graft.
| Device ID | K954848 |
| 510k Number | K954848 |
| Device Name: | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT |
| Classification | Graft, Vascular, Synthetic/biologic Composite |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Carolyn Tauber |
| Correspondent | Carolyn Tauber MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | MAL |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-23 |
| Decision Date | 1996-02-01 |
| Summary: | summary |