510(k) Report

Devices descending from P880003

29 later devices reach Cordis Ptca Dilatation Catheter 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—
+1K123473Hoper Ptca Balloon CatheterLepu Medical Technology (Beijing) Co., Ltd.20130—
+1K103808Sapphire NCOrbusneich Medical, Inc.201111—
+1K103657SapphireOrbusneich Medical, Inc.20115—
+1K110133Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation CatheterCreganna-Tactx Medical2011103
+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—
+2K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited20161—
+2K123264DK-Ptca Balloon CatheterIntuit Medical, LLC20130—
+2K121681Glider Ptca Balloon CatheterTrireme Medical, Inc.20124—
+2K111544Glider Ptca Balloon CatheterTrireme Medical, Inc.20126—
+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—
+3K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited20180—
+3K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+3K150292Chocolate PTCA Balloon CatheterTrireme Medical, LLC20152—
+3K133633Chocolate Ptca Bolloon CatheterTrireme Medical, Inc.20143—
+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—
+4K153682Chocolate XD PTCA Balloon CatheterTrireme Medical, LLC20161—
+5K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…Vascular Solutions, LLC20240—