510(k) Report

Devices descending from K060555

15 later devices reach Spraygenix Cryo Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc.20120—
+1K101825Cryoballoon Ablation SystemC2 Therapeutics201011—
+1K072651Cryospray Ablation System, Model CC2-NamCSA Medical, Inc.20070—
+1K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.200713—
+2K131523Cryoballoon Focal Ablation SystemC2 Therapeutics2013102
+3K160994C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc.20160—
+3K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+3K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc.20158—
+4K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+4K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+4K153541Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc.20160—
+5K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+6K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+7K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+8K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—