CRYOBALLOON FOCAL ABLATION SYSTEM
FDA 510(k) clearance K131523 · decided 2013-08-22
Clearance details
- K-number
- K131523
- Device name
- CRYOBALLOON FOCAL ABLATION SYSTEM
- Applicant
- C2 Therapeutics
- Decision
- Substantially Equivalent
- Date received
- 2013-05-28
- Decision date
- 2013-08-22
- Days to decision
- 86 days
- Clearance type
- Special
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood, Ca, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cr recall (Z-2256-2018) | PENTAX of America Inc | 2018-06-05 |
| C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical U recall (Z-1477-2017) | C2 Therapeutics, Inc. | 2017-03-15 |