510(k) Report

Devices descending from P860019

69 later devices reach Scimed Ptca Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170941RX NC Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation20170—
+1K161901TrapLiner catheterVascular Solutions, Inc.20171—
+1K162253Trapper Exchange DeviceCreganna Medical Aslo Business AS Cregganna Tactx Medical20171—
+1K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation20160—
+1K160985Pantera ProBiotronik, Inc.20163—
+1K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+1K133852Apollo Balloon Dilatation CatheterBrosmed Medical20142—
+1K141025Artimes Balloon Dilatation CatheterBrosmed Medical20141—
+1K141236NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter…Boston Scientific Corporation201431
+1K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited20132—
+1K130714Progigy Support CatheterRadius Medical, LLC20134—
+1K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd.20125—
+1K122178Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash-C Ptca Balloon…Ostial Corporation20123—
+1K121196Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Boston Scientific Corp201281
+1K121667NC Quantum Apex Ptca Dilatation Catheter (Monorail)Boston Scientific Corp20128—
+1K121681Glider Ptca Balloon CatheterTrireme Medical, Inc.20124—
+1K113220Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Boston Scientific Corporation2012151
+1K111544Glider Ptca Balloon CatheterTrireme Medical, Inc.20126—
+1K103808Sapphire NCOrbusneich Medical, Inc.201111—
+1K103657SapphireOrbusneich Medical, Inc.20115—
+1K110133Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation CatheterCreganna-Tactx Medical2011103
+2K242969Pantera Pro; Pantera LEOBiotronik, Inc.20241—
+2K223189Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.20230—
+2K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon…Dongguan TT Medical, Inc.20230—
+2K230705POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20230—
+2K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.20220—
+2K210012Tamarin Blue PTCA RX Dilatation CatheterNatec Medical, Ltd.20210—
+2K211393Selethru (TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20210—
+2K203390Artimes pro Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20210—
+2K191229TrapItImds Operations B.V.20200—
+2K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited20180—
+2K180088TrapLiner catheterVascular Solutions, Inc.20180—
+2K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon CathetersB. Braun Interventional Systems, Inc.20170—
+2K163660Pantera LEOBiotronik, Inc.20172—
+2K162434NC Gallant PTCA CatheterMedinol, Ltd.20171—
+2K163114Sapphire II PROOrbusneich Medical, Inc.20174—
+2K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation201621
+2K162209Sapphire NC PlusOrbusneich Medical, Inc.20169—
+2K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited20161—
+2K160823NC Quantum Apex PTCA Dilatation CatheterBoston Scientific Corporation20160—
+2K141933Filao NC RX Ptca Dilatation CatheterNatec Medical, Ltd.20150—
+2K150292Chocolate PTCA Balloon CatheterTrireme Medical, LLC20152—
+2K143160FOXTROT NC PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.20150—
+2K140910Centercross CatheterRoxwood Medical, Inc.20143—
+2K133633Chocolate Ptca Bolloon CatheterTrireme Medical, Inc.20143—
+2K123473Hoper Ptca Balloon CatheterLepu Medical Technology (Beijing) Co., Ltd.20130—
+2K131450Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X 8MM X…Ostial Corporation20132—
+2K130391Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter…Boston Scientific Corp201371
+2K123264DK-Ptca Balloon CatheterIntuit Medical, LLC20130—
+3K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+3K223022SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.20230—
+3K220629Emerge Monorail PTCA Dilatation CatheterBoston Scientific20220—
+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—
+3K173581Gallant PTCA Dilatation CatheterMedinol, Ltd.20180—
+3K153682Chocolate XD PTCA Balloon CatheterTrireme Medical, LLC20161—
+3K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x…Ostial Corporation20161—
+3K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.20260—
+4K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+4K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+4K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…Vascular Solutions, LLC20240—
+4K202578KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—
+4K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+5K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—