510(k) Report

Devices descending from P810046

18 later devices reach Simpson-Robert Coronary Balloon Dilatation Cathete through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+1K133852Apollo Balloon Dilatation CatheterBrosmed Medical20142—
+1K141025Artimes Balloon Dilatation CatheterBrosmed Medical20141—
+1K103808Sapphire NCOrbusneich Medical, Inc.201111—
+1K103657SapphireOrbusneich Medical, Inc.20115—
+2K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon…Dongguan TT Medical, Inc.20230—
+2K230705POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20230—
+2K203390Artimes pro Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20210—
+2K163114Sapphire II PROOrbusneich Medical, Inc.20174—
+2K162209Sapphire NC PlusOrbusneich Medical, Inc.20169—
+3K211807Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd.20211—
+3K202619KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—
+3K192344Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc.20193—
+3K182699Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20180—
+3K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+4K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+4K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+4K202578KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—