510(k) K965147 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jun 30, 1997 |
| Received | Dec 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2018 | Boston Scientific Corporation Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220 Terminated |
FGE | None listed |
| Dec 26, 2018 | Boston Scientific Corporation Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210 Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage o Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage o Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-7cm, M00539360, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainag Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for draina Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for draina Terminated |
FGE | None listed |
| Aug 25, 2010 | Boston Scientific Corporation FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for draina Terminated |
FGE | None listed |
| Sep 11, 2008 | Boston Scientific Corp Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210.
System is used for delivery of the stent to the biliary Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.