510(k) K023243 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
| Applicant | Sulzer Intratherapeutics, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Dec 13, 2002 |
| Received | Sep 30, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2003 | ev3, Inc. Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.