The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Vasular Graft.
| Device ID | K811510 |
| 510k Number | K811510 |
| Device Name: | GORE-TEX VASULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-27 |
| Decision Date | 1981-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H373RT04005015L3 | K811510 | 000 |
| H373R08050100L37 | K811510 | 000 |
| H373R10020020L3 | K811510 | 000 |
| H373R10030030L30 | K811510 | 000 |
| H373R120300303O | K811510 | 000 |
| H373R140300303Q | K811510 | 000 |
| H373R160200203Q | K811510 | 000 |
| H373R160300303S | K811510 | 000 |
| H373R200200203L | K811510 | 000 |
| H373R200300303N | K811510 | 000 |
| H373RD06005045L3Q | K811510 | 000 |
| H373RT05005015L3 | K811510 | 000 |
| H373RT08012030L3 | K811510 | 000 |
| H373RT10050100L3T | K811510 | 000 |
| H373R08012030L37 | K811510 | 000 |