The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Omnilink .035 Biliary Stent System.
| Device ID | K011506 |
| 510k Number | K011506 |
| Device Name: | OMNILINK .035 BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Curtis Truesdale |
| Correspondent | Curtis Truesdale GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-16 |
| Decision Date | 2001-06-15 |