The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex(r) Stretch Vascular Graft.
| Device ID | K903931 |
| 510k Number | K903931 |
| Device Name: | GORE-TEX(R) STRETCH VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 |
| Contact | Lee Olson |
| Correspondent | Lee Olson W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 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 | 1990-08-24 |
| Decision Date | 1990-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H373ST04073D | K903931 | 000 |
| H373ST100437 | K903931 | 000 |
| H373ST10083B | K903931 | 000 |
| H373S05013M | K903931 | 000 |
| H373S05023N | K903931 | 000 |
| H373S05043P | K903931 | 000 |
| H373S05073S | K903931 | 000 |
| H373S05083T | K903931 | 000 |
| H373S06013N | K903931 | 000 |
| H373S06023O | K903931 | 000 |
| H373S06033P | K903931 | 000 |
| H373S06043Q | K903931 | 000 |
| H373S06053R | K903931 | 000 |
| H373S06073T | K903931 | 000 |
| H373S06083U | K903931 | 000 |
| H373S06093V | K903931 | 000 |
| H373S07013O | K903931 | 000 |
| H373S07043R | K903931 | 000 |
| H373ST08093J | K903931 | 000 |
| H373ST08083I | K903931 | 000 |
| H373ST05073E | K903931 | 000 |
| H373ST060139 | K903931 | 000 |
| 00733132612611 | K903931 | 000 |
| H373ST06043C | K903931 | 000 |
| H373ST06053D | K903931 | 000 |
| H373ST06063E | K903931 | 000 |
| H373ST06073F | K903931 | 000 |
| H373ST06083G | K903931 | 000 |
| H373ST06093H | K903931 | 000 |
| H373ST07013A | K903931 | 000 |
| H373ST07043D | K903931 | 000 |
| H373ST07073G | K903931 | 000 |
| H373ST07083H | K903931 | 000 |
| H373ST08013B | K903931 | 000 |
| H373ST08043E | K903931 | 000 |
| H373ST08053F | K903931 | 000 |
| H373ST08073H | K903931 | 000 |
| H373S07073U | K903931 | 000 |
| H373S07083V | K903931 | 000 |
| H373SA14023X | K903931 | 000 |
| H373SA14033Y | K903931 | 000 |
| H373SA14043Z | K903931 | 000 |
| H373SA16023Z | K903931 | 000 |
| H373SA16033 | K903931 | 000 |
| H373SA16043 | K903931 | 000 |
| H373SA18023 | K903931 | 000 |
| H373SA18033 | K903931 | 000 |
| H373SA18043 | K903931 | 000 |
| H373SA20023U | K903931 | 000 |
| H373SA20033V | K903931 | 000 |
| H373SA20043W | K903931 | 000 |
| H373SA22023W | K903931 | 000 |
| H373SA22033X | K903931 | 000 |
| H373SA22043Y | K903931 | 000 |
| H373SA24023Y | K903931 | 000 |
| H373SA24033Z | K903931 | 000 |
| 00733132611560 | K903931 | 000 |
| H373S470553 | K903931 | 000 |
| H373S08013P | K903931 | 000 |
| H373S08043S | K903931 | 000 |
| H373S08053T | K903931 | 000 |
| H373S08073V | K903931 | 000 |
| H373S08083W | K903931 | 000 |
| H373S08093X | K903931 | 000 |
| H373S10043L | K903931 | 000 |
| H373S10083P | K903931 | 000 |
| H373S12023L | K903931 | 000 |
| H373S12033M | K903931 | 000 |
| H373S12043N | K903931 | 000 |
| 00733132611492 | K903931 | 000 |
| H373S460483 | K903931 | 000 |
| 00733132611515 | K903931 | 000 |
| 00733132611522 | K903931 | 000 |
| H373S470453 | K903931 | 000 |
| H373S470483 | K903931 | 000 |
| H373SA24043 | K903931 | 000 |