The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Hemashield Vantage (vascular Graft.
| Device ID | K961847 |
| 510k Number | K961847 |
| Device Name: | HEMASHIELD VANTAGE (VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 103 BAUER DR. P.O. BOX 530 Oakland, NJ 07436 |
| Contact | Carolyn Tauber |
| Correspondent | Carolyn Tauber MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 103 BAUER DR. P.O. BOX 530 Oakland, NJ 07436 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-13 |
| Decision Date | 1997-01-22 |
| Summary: | summary |