The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Vascular Graft.
| Device ID | K880167 |
| 510k Number | K880167 |
| Device Name: | GORE-TEX VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 |
| Contact | Barbara Boyce-nesbit |
| Correspondent | Barbara Boyce-nesbit W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-19 |
| Decision Date | 1988-05-18 |