510(k) K033393 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
| Applicant | Guidant Corp., Santa Clara CA, US |
| Decision | Unknown, Nov 10, 2003 |
| Received | Oct 23, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563 Terminated |
FGE | None listed |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010565. Terminated |
FGE | None listed |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566. Terminated |
FGE | None listed |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567. Terminated |
FGE | None listed |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.