510(k) K141335 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
EXPEL APD DRAINAGE CATHETER SYSTEM
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 17, 2014 |
| Received | May 21, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2015 | Boston Scientific Corporation Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits Terminated |
FGE | None listed |
| Mar 27, 2015 | Boston Scientific Corporation Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainag Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.