510(k) Report

Devices descending from K163114

4 later devices reach Sapphire II PRO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202619KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—
+1K182699Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20180—
+1K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+2K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—