510(k) Report

Devices descending from K930479

43 later devices reach Nylex Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K9716464F Nylex Angiography Catheter/5F Nylex Angiography CatheterCordis Corp.19971—
+1K9609751-4F Infiniti Angiographic CatheterCordis Corp.1996411
+2K1818364F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo…Cordis, A Cardinal Health Company20180—
+2K051561Asahi Angiographic CatheterAsahi Intecc Co., Ltd.20052—
+2K992051Radifocus OptitorqueTerumo Medical Corp.199932—
+2K982077Selector Diagnostic CatheterBoston Scientific Scimed, Inc.19980—
+2K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp.19977Class I
+3K232573INFINITI™ Ambi Angiographic CatheterCordis US Corp20230—
+3K193647Superpipe Angiographic CatheterSuzhou Hengrui Disheng Medical Co., Ltd.20200—
+3K102633Bioteq Angiographic CatheterBioteque Corp.20110—
+3K090427Ursa Angiographic CatheterCurative Medical Technology, Inc.20101—
+3K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20081—
+3K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.200818—
+3K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp.20089—
+4K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+4K193420XO Cross Support CatheterTransit Scientific20201—
+4K183305Crossing Support CatheterTractus Vascular, LLC20190—
+4K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit…Medtronic Vascular201602
+4K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp.20154—
+4K133539Total AcrossMedtronic Vascular20142—
+4K123818Ursa Angiographic CatheterCurative Medical Technology, Inc.20130—
+4K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+4K092372Heartrail Iii Guiding CatheterTerumo Corp.20092—
+4K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.200913—
+4K090913Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20090—
+5K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+5K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC20220—
+5K210322XO Cross Support CatheterTransit Scientific, LLC20210—
+5K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+5K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V.20203—
+5K180889Tractus Crossing Support CatheterTractus Vascular, LLC20180—
+5K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130—
+5K113335Heartrail Iii Guiding CatheterTerumo Corporation20120—
+5K110540Terumo Support CatheterTerumo Medical Corp.20116—
+6K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+6K231044R2P NavicrossTerumo Medical Corporation20231—
+6K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V.20232—
+6K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd.20220—
+6K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20181—
+6K173799NaviCross 0.018Terumo Corporation20182—
+7K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20241—
+7K211251ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20210—
+8K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20250—