510(k) K160994

C2 CryoBalloon Focal Pear Catheter by C2 Therapeutics, Inc. — Product Code GEH

K160994 is an FDA 510(k) premarket notification submitted by C2 Therapeutics, Inc. for the device "C2 CryoBalloon Focal Pear Catheter". The FDA issued a decision of Substantially Equivalent on May 19, 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.