510(k) Report

Devices descending from K152329

6 later devices reach Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+1K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+2K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+3K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+4K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+5K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—