The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Bifurcated Gore Tex Stretch Vascular Graft.
| Device ID | K904282 |
| 510k Number | K904282 |
| Device Name: | BIFURCATED GORE TEX 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 | James Lewis |
| Correspondent | James Lewis 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 | 1990-09-18 |
| Decision Date | 1991-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132612109 | K904282 | 000 |
| H373SB1601D35 | K904282 | 000 |
| H373SB1801D37 | K904282 | 000 |
| H373SB2001D30 | K904282 | 000 |
| H373SB2201D32 | K904282 | 000 |
| H373SB2401D34 | K904282 | 000 |
| 00733132611928 | K904282 | 000 |
| 00733132611942 | K904282 | 000 |
| 00733132611966 | K904282 | 000 |
| 00733132611980 | K904282 | 000 |
| 00733132612000 | K904282 | 000 |
| 00733132612024 | K904282 | 000 |
| H373SBT1801D3 | K904282 | 000 |
| H373SBT1802D3 | K904282 | 000 |
| 00733132612086 | K904282 | 000 |
| H373SB1401D33 | K904282 | 000 |