The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Modification To Omnilink .035 Biliary Stent System.
| Device ID | K032530 |
| 510k Number | K032530 |
| Device Name: | MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORPORATION 1525 O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Michelle Grossman |
| Correspondent | Michelle Grossman GUIDANT CORPORATION 1525 O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-15 |
| Decision Date | 2003-10-23 |
| Summary: | summary |