The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Eptfe Ringed Gore-tex Vascular Graft.
| Device ID | K991602 |
| 510k Number | K991602 |
| Device Name: | EPTFE RINGED GORE-TEX VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. Flagstaff,, AZ 86002 |
| Contact | Timothy J Ryan |
| Correspondent | Timothy J Ryan W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. Flagstaff,, AZ 86002 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H373RRT05030070L3L | K991602 | 000 |
| H373IRS06005020L39 | K991602 | 000 |
| 00733132607167 | K991602 | 000 |
| H373IRS06010020L35 | K991602 | 000 |
| H373IRS06040L36 | K991602 | 000 |
| 00733132607198 | K991602 | 000 |
| 00733132607204 | K991602 | 000 |
| H373IRST06005005L3 | K991602 | 000 |
| H373IRST06040040L3 | K991602 | 000 |
| H373IRST06060060L30 | K991602 | 000 |
| H373IRST06080080L34 | K991602 | 000 |
| H373IRST07040040L3 | K991602 | 000 |
| H373IRST07060060L31 | K991602 | 000 |
| H373IRST07080080L35 | K991602 | 000 |
| H373IRST08040040L3 | K991602 | 000 |
| H373IRST08060060L32 | K991602 | 000 |
| H373IRST08080080L36 | K991602 | 000 |
| H373RR06070080L3 | K991602 | 000 |
| 00733132607020 | K991602 | 000 |