510(k) K011806 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
| Applicant | Sulzer Intratherapeutics, Inc., Saint Paul MN, US |
| Decision | Unknown, Sep 7, 2001 |
| Received | Jun 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2006 | Ev3, Inc ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.