Cryoballoon Ablation System
510(k) K101825
Cryoballoon Ablation System is a Class II device made by C2 Therapeutics, cleared under FDA 510(k) K101825 on 29 Sep 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101825 | Date29 Sep 2010 | StatusActive |
Official records
- FDA 510(k) database K101825
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEH
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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