510(k) Report

Devices descending from K133258

20 later devices reach Trufreeze System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143625truFreeze SystemCSA Medical, Inc.2015191
+2K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+2K152668truFreeze SystemCSA Medical, Inc.201510—
+2K150920truFreeze SystemCSA Medical, Inc.201511—
+3K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+3K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+3K160273truFreeze SystemCsa Medial, Inc.20169—
+4K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+4K161557truFreeze SystemCSA Medical, Inc.20168—
+5K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+5K162695truFreeze SystemCSA Medical, Inc.20167—
+6K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+6K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+6K163244truFreeze SystemCSA Medical, Inc.20175—
+7K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+7K171626truFreeze SystemCSA Medical, Inc.20173—
+7K172041truFreeze SystemCSA Medical, Inc.20170—
+8K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+8K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+9K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—