510(k) K151054

Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System by C2 Therapeutics, Inc. — Product Code GEH

K151054 is an FDA 510(k) premarket notification submitted by C2 Therapeutics, Inc. for the device "Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System". The FDA issued a decision of Substantially Equivalent on July 7, 2015. 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.