Atlas FDA

CRE BALLOON DILATATION CATHETER

FDA 510(k) clearance K110833 · decided 2011-04-20

Clearance details

K-number
K110833
Device name
CRE BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2011-03-25
Decision date
2011-04-20
Days to decision
26 days
Clearance type
Special
Product code
FDT
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CRE Wireguided 6-8mm 240cm recall (Z-2632-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 8-10mm 240cm recall (Z-2633-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 10-12mm 240cm recall (Z-2634-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 12-15mm 240cm recall (Z-2635-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 15-18mm 240cm recall (Z-2636-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 18-20mm 240cm recall (Z-2637-2026)Boston Scientific Corporation2026-07-01

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