The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Selfx Xpert Biliary Stent, Models Ex8l2005, Ex8l3005, Ex8l4005, Ex8l2006, Ex8l3006, Ex8l4006, Ex8s2005, And Ex8s3005.
| Device ID | K033537 |
| 510k Number | K033537 |
| Device Name: | SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ABBOTT LABORATORIES 400 Saginaw Drive Redwood City, CA 94063 |
| Contact | Joanna Kuskowski |
| Correspondent | Joanna Kuskowski 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 | 2003-11-10 |
| Decision Date | 2003-12-10 |
| Summary: | summary |