510(k) K152329

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System by C2 Therapeutics, Inc. — Product Code GEH

K152329 is an FDA 510(k) premarket notification submitted by C2 Therapeutics, Inc. for the device "Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System". The FDA issued a decision of Substantially Equivalent on April 13, 2016. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. C2 Therapeutics, Inc. has at least 9 other 510(k) clearances on record.