510(k) Report

Devices descending from K203024

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+2K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—