The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Absolute .035 Self-expanding Biliary Stent System.
| Device ID | K033393 |
| 510k Number | K033393 |
| Device Name: | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Kelly Pike |
| Correspondent | Kelly Pike GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2003-11-10 |
| Summary: | summary |