510(k) K032025 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
SENTINOL NITINOL BILLARY STENT SYSTEM
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Unknown, Sep 25, 2003 |
| Received | Jun 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2006 | Boston Scientific Scimed Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.