The following data is part of a premarket notification filed by W.l. Gore & Associates with the FDA for Gore Hybrid Vascular Graft.
| Device ID | K093934 |
| 510k Number | K093934 |
| Device Name: | GORE HYBRID VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES 3250 W. KILTIE LANE Flagstaff, AZ 86001 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W.L. GORE & ASSOCIATES 3250 W. KILTIE LANE Flagstaff, AZ 86001 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H3730650HYB0910A3 | K093934 | 000 |
| H3730650HYB0810A3 | K093934 | 000 |
| 00733132618910 | K093934 | 000 |
| H3730650HYB0710A3 | K093934 | 000 |
| H3730650HYB0905A3 | K093934 | 000 |
| H3730650HYB0805A3 | K093934 | 000 |
| H3730650HYB0705A3 | K093934 | 000 |
| H3730650HYB0605A3 | K093934 | 000 |