The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Xpert Self-expanding Transhepatic Biliary Stent System.
| Device ID | K050534 |
| 510k Number | K050534 |
| Device Name: | XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ABBOTT LABORATORIES 400 Saginaw Drive Redwood City, CA 94063 |
| Contact | Joanna Develter |
| Correspondent | Joanna Develter ABBOTT LABORATORIES 400 Saginaw Drive Redwood City, CA 94063 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-05-20 |
| Summary: | summary |