510(k) Report

Devices descending from K103808

11 later devices reach Sapphire NC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon…Dongguan TT Medical, Inc.20230—
+1K163114Sapphire II PROOrbusneich Medical, Inc.20174—
+1K162209Sapphire NC PlusOrbusneich Medical, Inc.20169—
+2K211807Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd.20211—
+2K202619KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—
+2K192344Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc.20193—
+2K182699Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20180—
+2K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+3K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+3K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+3K202578KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—