510(k) K131523

CRYOBALLOON FOCAL ABLATION SYSTEM by C2 Therapeutics — Product Code GEH

K131523 is an FDA 510(k) premarket notification submitted by C2 Therapeutics for the device "CRYOBALLOON FOCAL ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 22, 2013. 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.