510(k) K190194

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge by Pentax Medical, A Division Of Pentax Of America, Inc. — Product Code GEH

K190194 is an FDA 510(k) premarket notification submitted by Pentax Medical, A Division Of Pentax Of America, Inc. for the device "C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge". The FDA issued a decision of Substantially Equivalent on May 31, 2019. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Pentax Medical, A Division Of Pentax Of America, Inc. has 1 other 510(k) clearance on record.