510(k) Report

Devices descending from K190194

3 later devices reach C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+2K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+3K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—