The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore-tex Vascular Graft; Gore-tex Stretch Vascular Graft.
| Device ID | K013250 |
| 510k Number | K013250 |
| Device Name: | GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Timothy J Rynn |
| Correspondent | Timothy J Rynn W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-28 |
| Decision Date | 2001-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H373VT35010LA32 | K013250 | 000 |
| H373ST03010A3G | K013250 | 000 |
| H373ST03015A3L | K013250 | 000 |
| H373ST04010A3H | K013250 | 000 |
| H373ST04015A3M | K013250 | 000 |
| H373ST05010A3I | K013250 | 000 |
| H373ST05015A3N | K013250 | 000 |
| H373ST06015A3O | K013250 | 000 |
| H373ST35005A3P | K013250 | 000 |
| H373ST35010A3L | K013250 | 000 |
| H373ST35015A3Q | K013250 | 000 |
| H373VT03010LA3 | K013250 | 000 |
| H373VT04010LA3 | K013250 | 000 |
| H373VT05010LA3 | K013250 | 000 |
| H373VT35005LA36 | K013250 | 000 |
| H373ST03005A3K | K013250 | 000 |