510(k) K112994 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
CRE DITATATION BALLON
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Feb 10, 2012 |
| Received | Oct 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112994
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 6-8mm 240cm Open, Classified |
FGE | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 8-10mm 240cm Open, Classified |
FGE | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 10-12mm 240cm Open, Classified |
FGE | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 12-15mm 240cm Open, Classified |
FGE | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 15-18mm 240cm Open, Classified |
FGE | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 18-20mm 240cm Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.