510(k) K110833 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
CRE BALLOON DILATATION CATHETER
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Apr 20, 2011 |
| Received | Mar 25, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110833
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 6-8mm 240cm Open, Classified |
FDT | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 8-10mm 240cm Open, Classified |
FDT | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 10-12mm 240cm Open, Classified |
FDT | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 12-15mm 240cm Open, Classified |
FDT | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 15-18mm 240cm Open, Classified |
FDT | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 18-20mm 240cm Open, Classified |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.