510(k) Report

Devices descending from P790017

67 later devices reach Usci Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland20260—
+1K160985Pantera ProBiotronik, Inc.20163—
+1K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+1K143480Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc.201533
+1K133852Apollo Balloon Dilatation CatheterBrosmed Medical20142—
+1K141025Artimes Balloon Dilatation CatheterBrosmed Medical20141—
+1K141090NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc.20142—
+1K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited20132—
+1K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd.20125—
+1K103808Sapphire NCOrbusneich Medical, Inc.201111—
+1K103657SapphireOrbusneich Medical, Inc.20115—
+1K103095Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland201013—
+1K031211Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular200329—
+2K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic Ireland20260—
+2K261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic Ireland20260—
+2K242969Pantera Pro; Pantera LEOBiotronik, Inc.20241—
+2K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon…Dongguan TT Medical, Inc.20230—
+2K230705POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20230—
+2K212393OPN NC PTCA Dilatation CatheterSis Medical AG20220—
+2K210012Tamarin Blue PTCA RX Dilatation CatheterNatec Medical, Ltd.20210—
+2K203390Artimes pro Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20210—
+2K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited20180—
+2K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+2K163372RX Takeru Balloon Dilatation CatheterKANEKA Corporation20171—
+2K163660Pantera LEOBiotronik, Inc.20172—
+2K163114Sapphire II PROOrbusneich Medical, Inc.20174—
+2K162209Sapphire NC PlusOrbusneich Medical, Inc.20169—
+2K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited20161—
+2K141933Filao NC RX Ptca Dilatation CatheterNatec Medical, Ltd.20150—
+2K082670Modification to: Attain Prevail 6228CTH80 Steerable Catheter SetMedtronic, Inc.20080—
+2K052575Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical20064—
+2K042194Attain Select 6238TEL Guide Catheter Set for Left-Heart DeliveryMedtronic Vascular200417—
+2K032622Attain Prevail Left Heart Delivery System Moddel, 6228SYSMedtronic Vascular20035—
+3K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+3K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+3K211807Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd.20211—
+3K202619KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—
+3K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical)20200—
+3K192344Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc.20193—
+3K182699Selethru PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20180—
+3K172264OTW Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation20180—
+3K103083Agilis ES Steerable IntroducerSt Jude Medical20112—
+3K053431Attain Select II 6248DEL Delivery Catheter SystemMedtronic, Ireland200614—
+3K053217CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147…St Jude Medical200605
+3K053277CPS Direct SL Outer CatheterSt Jude Medical200601
+3K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043—
+4K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+4K202578KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—
+4K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+4K123153Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…Medtronic, Ireland20133—
+4K080428Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters…Medtronic, Inc.200813—
+4K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+4K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051—
+5K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+5K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+5K171819Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica20180—
+5K090659Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart…Medtronic, Inc.200912—
+5K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+6K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic20220—
+6K112917Attain LDS 6216A Left Heart Delivery System, Attain Access 6218A Left Heart Delivery…Medtronic, Inc.20110—
+6K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+7K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+8K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+8K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+9K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+9K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+10K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—