510(k) K050725 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PROTEGE GPS SELF-EXPANDING NITINOL STENT
| Applicant | Ev3 Corporation, Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 20, 2005 |
| Received | Mar 21, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050725
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2010 | Ev3, Inc. ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only.
ev3 Inc. 4600 Nathan Lane, Plymouth, MN Protg " Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.