510(k) Report

Devices descending from K915414

66 later devices reach Terumo Angiogtaphic Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093004Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc.20104—
+1K090040Radifocus Glidecath (or Radifocus Glidecath XP)Terumo Medical Corp.200911—
+1K060666Carotid Access KitTerumo Medical Corp.20060—
+1K992051Radifocus OptitorqueTerumo Medical Corp.199932—
+1K981359GT LeggieroTerumo Medical Corp.199914—
+2K193647Superpipe Angiographic CatheterSuzhou Hengrui Disheng Medical Co., Ltd.20200—
+2K191608Impress Angiographic CatheterMerit Medical Systems, Inc.20192—
+2K130378Respiguide Delivery SystemRespicardia20130—
+2K110459Surefire Infusion Catheter SystemSurefire Medical, Inc.20119—
+2K102979Nexgen Peripheral Guide CatheterNexgen Medical Systems, Inc.20110—
+2K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20081—
+2K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.200818—
+2K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp.20089—
+2K033583ProgreatTerumo Medical Corp.200313—
+3K233268Impress Angiographic CatheterMerit Medical Systems, Inc.20240—
+3K233975Zoom 6F Insert CathetersImperative Care, Inc.20240—
+3K232536Soldier MicrocatheterEmbolx, Inc.20240—
+3K211078Progreat LambdaTerumo Clinical Supply Co., Ltd.20210—
+3K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+3K193420XO Cross Support CatheterTransit Scientific20201—
+3K183305Crossing Support CatheterTractus Vascular, LLC20190—
+3K173430SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd.20183—
+3K170223ProgreatAshitaka Factory of Terumo Corporation20171—
+3K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit…Medtronic Vascular201602
+3K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp.20154—
+3K142817IntraNovo 25 MicrocatheterTexasmedical Technologies, Inc.20151—
+3K133539Total AcrossMedtronic Vascular20142—
+3K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc.20127—
+3K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+3K113737Surefire Guide SheathSurefire Medical, Inc.20120—
+3K092372Heartrail Iii Guiding CatheterTerumo Corp.20092—
+3K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.200913—
+3K090913Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20090—
+3K033913ProgreatTerumo Medical Corp.20043—
+4K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+4K231293Drakon™ and Sequre® MicrocathetersAccurate Medical Therapeutics20230—
+4K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC20220—
+4K210322XO Cross Support CatheterTransit Scientific, LLC20210—
+4K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+4K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V.20203—
+4K203487Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd.20201—
+4K202797Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd.20202—
+4K180889Tractus Crossing Support CatheterTractus Vascular, LLC20180—
+4K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd.20181—
+4K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.20170—
+4K153125IntraNovo MicrocatheterTexasmedical Technologies, Inc.20160—
+4K143588Surefire Infusion System 021Surefire Medical, Inc.20156—
+4K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130—
+4K113335Heartrail Iii Guiding CatheterTerumo Corporation20120—
+4K110540Terumo Support CatheterTerumo Medical Corp.20116—
+5K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+5K231044R2P NavicrossTerumo Medical Corporation20231—
+5K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V.20232—
+5K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd.20220—
+5K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.20220—
+5K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20181—
+5K173799NaviCross 0.018Terumo Corporation20182—
+5K171355Surefire Precision Infusion SystemSurefire Medical, Inc.20174—
+5K160662Surefire Infusion SystemSurefire Medical, Inc.20165—
+6K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20241—
+6K211251ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20210—
+6K193107TriSalus Infusion SystemTrisalus Life Sciences20190—
+6K180677Surefire Spark Infusion SystemSurefire Medical, Inc.20182—
+7K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20250—
+7K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences20231—
+8K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences20260—