510(k) Report

Devices descending from K131523

10 later devices reach Cryoballoon Focal Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160994C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc.20160—
+1K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+1K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc.20158—
+2K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+2K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+2K153541Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc.20160—
+3K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+4K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+5K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+6K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—