The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Ptfe Ringed Gore-tex Vascular Graft.
| Device ID | K991683 |
| 510k Number | K991683 |
| Device Name: | PTFE RINGED GORE-TEX VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff, AZ 86001 -0300 |
| Contact | Timothy J Rynn |
| Correspondent | Timothy J Rynn W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff, AZ 86001 -0300 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-17 |
| Decision Date | 1999-09-08 |
| Summary: | summary |