510(k) Report

Devices descending from K163420

3 later devices reach UltraScore Focused Force PTA Balloon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+1K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+2K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—