510(k) K032580 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Unknown, Oct 22, 2003 |
| Received | Aug 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2008 | Ev3, Inc Ev3 Protege GPS Biliary Stent Systems
6 mm, 60 mm, 120cm, .35, 6Fr, OTW
Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920
REF SERB65-06-60-120
Lot 2675311
Use before 2009-01-01
Sterile EO
Intended Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.