510(k) K061566 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PRIMUS GPS BILIARY STENT SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Unknown, Aug 31, 2006 |
| Received | Jun 6, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2008 | Ev3, Inc ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System.
Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35 Terminated |
FGE | None listed |
| Sep 26, 2008 | Ev3, Inc ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System.
Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-1 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.