C2 Cryoballoon Ablation System
FDA 510(k) clearance K161202 · decided 2017-01-05
Clearance details
- K-number
- K161202
- Device name
- C2 Cryoballoon Ablation System
- Applicant
- C2 Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-28
- Decision date
- 2017-01-05
- Days to decision
- 252 days
- Clearance type
- Traditional
- 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 Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical U recall (Z-1477-2017) | C2 Therapeutics, Inc. | 2017-03-15 |