The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Fep Ringed Gore-tex Stretch Vascualr Graft With Removable Rings.
| Device ID | K933943 |
| 510k Number | K933943 |
| Device Name: | FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. P.O. BOX 2200 Flagstaff, AZ 86003 -2200 |
| Contact | James D Lewis |
| Correspondent | James D Lewis W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. P.O. BOX 2200 Flagstaff, AZ 86003 -2200 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-16 |
| Decision Date | 1993-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H373SRRT08070100L37 | K933943 | 000 |
| H373SRRT06060060L39 | K933943 | 000 |
| H373SRRT06050050L37 | K933943 | 000 |
| H373SRRT06040050L36 | K933943 | 000 |
| H373SRRT06030080L38 | K933943 | 000 |
| H373SRRT06030070L37 | K933943 | 000 |
| H373SRRT06030040L34 | K933943 | 000 |
| H373SRRT06010010L3 | K933943 | 000 |
| H373SRRT05060070L39 | K933943 | 000 |
| H373SRRT05030070L36 | K933943 | 000 |
| H373SRRT06060070L3A | K933943 | 000 |
| H373SRRT06060080L3B | K933943 | 000 |
| H373SRRT08070080L3E | K933943 | 000 |
| H373SRRT08070070L3D | K933943 | 000 |
| H373SRRT08040050L38 | K933943 | 000 |
| H373SRRT08030080L3A | K933943 | 000 |
| H373SRRT08030070L39 | K933943 | 000 |
| H373SRRT08030040L36 | K933943 | 000 |
| H373SRRT06070080L3C | K933943 | 000 |
| H373SRRT06070070L3B | K933943 | 000 |
| H373SRRT06060100L34 | K933943 | 000 |
| H373SRRT05030040L33 | K933943 | 000 |