The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Omnilink .035 Biliary Stent System.
| Device ID | K053459 |
| 510k Number | K053459 |
| Device Name: | OMNILINK .035 BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORPORATION 26531 YNEZ ROAD Temecula, CA 92591 |
| Contact | Sylvia Hernandez |
| Correspondent | Sylvia Hernandez GUIDANT CORPORATION 26531 YNEZ ROAD Temecula, CA 92591 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-13 |
| Decision Date | 2006-04-12 |
| Summary: | summary |