510(k) K130484 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 9, 2013 |
| Received | Feb 25, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545890 Open, Classified |
FGE | None listed |
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545900 Open, Classified |
FGE | None listed |
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN:M00545910 Open, Classified |
FGE | None listed |
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 6MM 4CM-
-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545920 Open, Classified |
FGE | None listed |
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545930 Open, Classified |
FGE | None listed |
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545940 Open, Classified |
FGE | None listed |
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545950 Open, Classified |
FGE | None listed |
| Oct 21, 2021 | Boston Scientific Corporation HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545960 Open, Classified |
FGE | None listed |
| Sep 16, 2020 | Boston Scientific Corporation Hurricane RX Biliary Balloon Dilatation Catheter
Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960
The device is a double lumen catheter with a ba Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.