510(k) Report

Devices descending from K010579

86 later devices reach Stent Support Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0307795F Medtronic Launcher Guide CatheterMedtronic Vascular2003107
+1K030201Modification to Export Aspiration CatheterMedtronic Vascular200360—
+1K021256Z3 Guide CatheterMedtronic Vascular20022452
+2K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S20140—
+2K140034Surefire Guiding CatheterSurefire Medical, Inc.20142—
+2K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130—
+2K1326735F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding…Medtronic, Inc.20130Class I
+2K120585Convey Guiding CatheterPendracare International, B.V.20122—
+2K103386Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide…Medtronic, Inc.201111
+2K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+2K0624205F Sherpa Active NX Guide CatheterMedtronic Vascular20062—
+2K0424896F Z4 Guide CatheterMedtronic Vascular20048Class I
+2K040869Export CatheterMedtronic Vascular200459—
+2K0227647F Launcher Guide CatheterMedtronic Vascular20021113
+3K250972Primum Hydrophilic Guiding CatheterPendracare20250—
+3K233858TriSalus TriGuideTM Guiding CatheterTrisalus Life Sciences20230—
+3K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F…Medtronic Vascular20230—
+3K210009Guiding CatheterCenterPoint Systems, LLC20210—
+3K162359Surefire Guiding CatheterSurefire Medical, Inc.20160—
+3K132197Convey 7F Guiding Catheter, Convey 8F Guiding CatheterPendracare International, B.V.20130—
+3K091188Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd.20101—
+3K0834226F Taiga Guiding CatheterMedtronic Vascular20091Class I
+3K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+3K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+3K071727QXT Extraction CatheterVascular Solutions, Inc.200712—
+3K061958Medtronic Export XT CatheterMedtronic Vascular2006301
+3K053372Lbi Catheter SystemLumen Biomedical, Inc.200610—
+3K0604188F Sherpa NX Guide CatheterMedtronic Vascular20063—
+3K060092Quickcat Extraction CatheterKensey Nash Corp.200621
+3K0518467F Sherpa NX Guide CatheterMedtronic Vascular20051—
+3K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+3K050139Modification to: Export CatheterMedtronic Vascular200514—
+3K030671Medtronioc 7F Launcher Biopsy Guide Catheter, Model LA7RVBB, Medtronic 8F Launcher…Medtronic Vascular20030—
+3K0234028F Launcher Guide CatheterMedtronic Vascular2002818
+4K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterMedtronic Vascular20230—
+4K192296Medtronic 6F Taiga Guiding CatheterMedtronic Vascular20190—
+4K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+4K131998Aspire RX-LP6 Aspiration CatheterControl Medical Technology, LLC20131—
+4K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+4K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+4K120808Export XT Catheter, Export AP CatheterMedtronic, Inc.20125—
+4K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+4K112382Terumo Aspriation CatheterTerumo Medical Corporation20110—
+4K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+4K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+4K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+4K081573Medtronic Export AP CatheterMedtronic Vascular200811—
+4K073519Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp.200811
+4K073627Flexor Evac Aspiration CatheterCook, Inc.20080—
+4K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc.200711—
+4K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K071529Xtract Catheter SystemLumen Biomedical, Inc.200791
+4K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+4K052523Proxis SystemVelocimed, Inc.20062—
+5K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+5K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+5K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+5K172716V2K Rinspiration SystemV2k Medical, Inc.20180—
+5K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—
+5K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+5K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+5K130536Export Advance Aspiration CatheterMedtronic, Inc.20134—
+5K091703HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131Concentric Medical, Inc.20090—
+5K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc.200910—
+5K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+5K073563Modification to Proxis SystemSt Jude Medical20080—
+5K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+6K253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.20260—
+6K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+6K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+6K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I
+6K163031Bunegin-Albin Air Aspiration SetCook Incorporated20170—
+6K162467Twin-Pass TorqueVascular Solutions, Inc.20172—
+6K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+6K152335Export Advance Aspiration CatheterMedtronic, Inc.20152—
+6K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc.201041
+6K090977Piggyback Wire ConverterVascular Solutions, Inc.20090—
+7K200324NHancer RxImds Operations B.V.20201—
+7K190619Aspiron (TM) Aspiration CatheterMeril Life Sciences Private Limited20190—
+7K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—
+7K161506Penumbra Aspiration SystemPenumbra, Inc.20163—
+8K210431ReCrossImds Operations B.V.20210—
+8K163618INDIGO Aspiration SystemPenumbra, Inc.20172—
+9K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.20181—
+10K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.20220—