The following data is part of a premarket notification filed by Boston Scientific/medi-tech with the FDA for Hemashield Gold Woven Double Velour Vascular Graft - Branch Graft.
| Device ID | K012952 |
| 510k Number | K012952 |
| Device Name: | HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | BOSTON SCIENTIFIC/MEDI-TECH ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Jennifer Bolton |
| Correspondent | Jennifer Bolton BOSTON SCIENTIFIC/MEDI-TECH ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-10-02 |
| Summary: | summary |