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 | K014215 |
| 510k Number | K014215 |
| 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 86002 |
| Contact | Jacqueline Kalbach |
| Correspondent | Jacqueline Kalbach W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. Flagstaff,, AZ 86002 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-12-19 |
| Summary: | summary |