510(k) K101825
K101825 is an FDA 510(k) premarket notification submitted by C2 Therapeutics for the device "CRYOBALLOON ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 29, 2010. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. C2 Therapeutics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2010
- Date Received
- July 1, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type