The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Axillobifemoral Gore-tex Cascular Graft,bifurcated.
| Device ID | K941981 |
| 510k Number | K941981 |
| Device Name: | AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff, AZ 86001 -0300 |
| Contact | Vicki Lewis |
| Correspondent | Vicki Lewis W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff, AZ 86001 -0300 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-14 |
| Decision Date | 1994-07-20 |