The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Aor-tex Vascular Graft.
Device ID | K933987 |
510k Number | K933987 |
Device Name: | AOR-TEX VASCULAR GRAFT |
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 Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-17 |
Decision Date | 1994-05-17 |