510(k) K140630 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
WALLFLEX BILIARY RX STENT SYSTEM
| Applicant | Boston Scientific, Marlboro MA, US |
| Decision | Unknown, May 23, 2014 |
| Received | Mar 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140630
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2020 | Boston Scientific Corporation WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neop Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.