CRE BALLOON DILATATION CATHETER— 510(k) K110833
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K110833 for CRE BALLOON DILATATION CATHETER, Substantially Equivalent on 2011-04-20. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code FDT
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
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- K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
More clearances from Boston Scientific Corporation
view allAdverse events under product code FDT
product code FDT- Death
- 86
- Injury
- 1,954
- Malfunction
- 14,912
- Total
- 16,952
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110833
K-number listed on FDA's recall record- Z-2632-2026 — CRE Wireguided 6-8mm 240cm
- Z-2633-2026 — CRE Wireguided 8-10mm 240cm
- Z-2634-2026 — CRE Wireguided 10-12mm 240cm
- Z-2635-2026 — CRE Wireguided 12-15mm 240cm
- Z-2636-2026 — CRE Wireguided 15-18mm 240cm
- Z-2637-2026 — CRE Wireguided 18-20mm 240cm
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110833.
Data sourced from openFDA. This site is unofficial and independent of the FDA.