The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Xpand Balloon-expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605.
| Device ID | K041962 |
| 510k Number | K041962 |
| Device Name: | XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ABBOTT LABORATORIES 400 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Joanna Kuskowski |
| Correspondent | Joanna Kuskowski ABBOTT LABORATORIES 400 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-21 |
| Decision Date | 2004-10-01 |
| Summary: | summary |