CRE DITATATION BALLON
FDA 510(k) clearance K112994 · decided 2012-02-10
Clearance details
- K-number
- K112994
- Device name
- CRE DITATATION BALLON
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-10-07
- Decision date
- 2012-02-10
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- 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
| Record | Firm | Date |
|---|---|---|
| CRE Pro Wireguided 6-8mm 240cm recall (Z-2626-2026) | Boston Scientific Corporation | 2026-07-01 |
| CRE Pro Wireguided 8-10mm 240cm recall (Z-2627-2026) | Boston Scientific Corporation | 2026-07-01 |
| CRE Pro Wireguided 10-12mm 240cm recall (Z-2628-2026) | Boston Scientific Corporation | 2026-07-01 |
| CRE Pro Wireguided 12-15mm 240cm recall (Z-2629-2026) | Boston Scientific Corporation | 2026-07-01 |
| CRE Pro Wireguided 15-18mm 240cm recall (Z-2630-2026) | Boston Scientific Corporation | 2026-07-01 |
| CRE Pro Wireguided 18-20mm 240cm recall (Z-2631-2026) | Boston Scientific Corporation | 2026-07-01 |
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|---|---|---|
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| ENROUTE® Transcarotid Stent System (P140026/S032) | Boston Scientific Corporation | 2025-10-23 |
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