The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Viabil Biliary Endoprosthesis.
| Device ID | K041423 |
| 510k Number | K041423 |
| Device Name: | VIABIL BILIARY ENDOPROSTHESIS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-28 |
| Decision Date | 2004-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132615834 | K041423 | 000 |
| 00733132615537 | K041423 | 000 |
| 00733132615520 | K041423 | 000 |
| 00733132615513 | K041423 | 000 |
| 00733132615506 | K041423 | 000 |
| 00733132615490 | K041423 | 000 |
| 00733132615483 | K041423 | 000 |
| 00733132615476 | K041423 | 000 |
| 00733132615469 | K041423 | 000 |
| 00733132615452 | K041423 | 000 |
| 00733132615445 | K041423 | 000 |
| 00733132615438 | K041423 | 000 |
| 00733132615421 | K041423 | 000 |
| 00733132615551 | K041423 | 000 |
| 00733132615575 | K041423 | 000 |
| 00733132615810 | K041423 | 000 |
| 00733132615797 | K041423 | 000 |
| 00733132615773 | K041423 | 000 |
| 00733132615759 | K041423 | 000 |
| 00733132615735 | K041423 | 000 |
| 00733132615711 | K041423 | 000 |
| 00733132615698 | K041423 | 000 |
| 00733132615674 | K041423 | 000 |
| 00733132615650 | K041423 | 000 |
| 00733132615636 | K041423 | 000 |
| 00733132615612 | K041423 | 000 |
| 00733132615599 | K041423 | 000 |
| 00733132615414 | K041423 | 000 |