510(k) Report

Devices descending from K992051

32 later devices reach Radifocus Optitorque through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193647Superpipe Angiographic CatheterSuzhou Hengrui Disheng Medical Co., Ltd.20200—
+1K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20081—
+1K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.200818—
+1K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp.20089—
+2K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+2K193420XO Cross Support CatheterTransit Scientific20201—
+2K183305Crossing Support CatheterTractus Vascular, LLC20190—
+2K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit…Medtronic Vascular201602
+2K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp.20154—
+2K133539Total AcrossMedtronic Vascular20142—
+2K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+2K092372Heartrail Iii Guiding CatheterTerumo Corp.20092—
+2K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.200913—
+2K090913Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20090—
+3K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+3K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC20220—
+3K210322XO Cross Support CatheterTransit Scientific, LLC20210—
+3K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+3K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V.20203—
+3K180889Tractus Crossing Support CatheterTractus Vascular, LLC20180—
+3K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130—
+3K113335Heartrail Iii Guiding CatheterTerumo Corporation20120—
+3K110540Terumo Support CatheterTerumo Medical Corp.20116—
+4K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+4K231044R2P NavicrossTerumo Medical Corporation20231—
+4K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V.20232—
+4K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd.20220—
+4K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20181—
+4K173799NaviCross 0.018Terumo Corporation20182—
+5K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20241—
+5K211251ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20210—
+6K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20250—