510(k) K060057 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Unknown, Mar 8, 2006 |
| Received | Jan 9, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060057
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2010 | Ev3, Inc. ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Terminated |
FGE | None listed |
| Dec 1, 2009 | Ev3, Inc. Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx onl Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.