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 |