The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex(r) Vascular Grafts, Process Change.
| Device ID | K914447 |
| 510k Number | K914447 |
| Device Name: | GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. Flagstaff, AZ 86003 -3000 |
| Contact | Dawn Lopez |
| Correspondent | Dawn Lopez W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. Flagstaff, AZ 86003 -3000 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-04 |
| Decision Date | 1991-11-05 |