510(k) Report

Devices descending from K062896

26 later devices reach V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102360Icesence 3IceCure Medical, Ltd.2010251
+2K183213IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd.20193—
+2K133258Trufreeze SystemCSA Medical, Inc.2014201
+3K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd.20242—
+3K143625truFreeze SystemCSA Medical, Inc.2015191
+4K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd.20260—
+4K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+4K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+4K152668truFreeze SystemCSA Medical, Inc.201510—
+4K150920truFreeze SystemCSA Medical, Inc.201511—
+5K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+5K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+5K160273truFreeze SystemCsa Medial, Inc.20169—
+6K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+6K161557truFreeze SystemCSA Medical, Inc.20168—
+7K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+7K162695truFreeze SystemCSA Medical, Inc.20167—
+8K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+8K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+8K163244truFreeze SystemCSA Medical, Inc.20175—
+9K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+9K171626truFreeze SystemCSA Medical, Inc.20173—
+9K172041truFreeze SystemCSA Medical, Inc.20170—
+10K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+10K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+11K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—