510(k) Report

Devices descending from K011084

81 later devices reach Mandrel Guidewire Assembly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140593Advance Salivary Balloon Catheter with Wire GuideCook, Inc.20140—
+1K142397Predicate III GuidewireLake Region Medical20140—
+1K140482Mandrel GuidewireLake Region Medical20141—
+1K140485Mandrel GuidewireLake Region Medical20142—
+1K081775The Medcomp .010 Vascular GuidewiresMedcomp20090—
+1K072864ST. Jude Medical, CPS Duo Left Heart Lead Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi20080—
+1K080144Mandrel Guidewires or M-WiresLake Region Mfg., Inc.20083—
+1K040592Cordis Steer-IT Deflecting Tip GuidewireCordis Corp.20042—
+1K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Genesis Medical Interventional, Inc.200451—
+1K033758Hydrophilic GuidewireLake Region Mfg., Inc.20034—
+1K013024Selectiva GuidewireNeometrics, Inc.200115—
+2K143563Infusion Aspiration Catheter SystemInari Medical, Inc.201535—
+2K142393Predicate Iii GuidewireLake Region Medical20141—
+2K110739Entellus Medical Sinus GuidewireEntellus Medical, Inc.20110—
+2K101729Neowire Pta/Ptca GuidewireNeometrics, Inc.20100—
+2K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc.20097—
+2K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+2K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071—
+2K033321Selectiva SB GuidewireNeometrics, Inc.20031—
+2K031652Vascupuncture Picc GuidewireNeometrics, Inc.200312—
+3K241784Arrow® Nitinol WireTeleflex Medical20240—
+3K201541FlowTriever Retrieval/Aspiration SystemInari Medical20204—
+3K182835WOLF Thrombectomy Device880 Medical, LLC20195—
+3K180722CAPERE Thrombectomy SystemKp Medcure, Inc.20185—
+3K180466FlowTriever Retrieval/Aspiration SystemInari Medical, Inc.20185—
+3K171897Approach CTO Microwire GuideCook Incorporated201703
+3K163549ClotTriever Thrombectomy SystemInari Medical, Inc.20176—
+3K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical20166—
+3K152097Retraction AspiratorInari Medical20150—
+3K132281ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc.20136—
+3K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+3K070150Vascupuncture Picc GuidewireNeometrics, Inc.20071—
+3K043398Modification to Vascupuncture Picc GuidewireNeometrics, Inc.200510—
+3K040786Vascupuncture Picc Guidewire with Hydro-Silk CoatingNeometrics, Inc.200411—
+4K250088FlowTriever2 CatheterInari Medical, Inc.20250—
+4K240397AlphaVac MMA F1885 System (H787253020)AngioDynamics, Inc.20240—
+4K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+4K221204Excipio SV Thrombectomy DeviceContego Medical, Inc.20222—
+4K220600Artix Thrombectomy DeviceInari Medical20222—
+4K210530WOLF Thrombectomy System, 6FDevoro Medical, Inc.20210—
+4K201085NeVa PV Thrombectomy DeviceVesalio20212—
+4K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200—
+4K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+4K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+4K200101WOLF Thrombectomy V SystemDevoro Medical, Inc.20204—
+4K200314Capere Thrombectomy SystemVascular Medcure, Inc.20201—
+4K183179CAPERE Thrombectomy SystemVascular Medcure, Inc.20192—
+4K181325FlowTriever Retrieval/Aspiration SystemInari Medical, Inc.20182—
+4K173672FlowTriever Retrieval/Aspiration System, Aspiration Guide CatheterInari Medical20185—
+4K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical20175—
+4K112631Vsi GuidewireVascular Solutions, Inc.20117—
+5K254211pVasc Net Mechanical Thrombectomy DeviceVesalio, Inc.20260—
+5K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+5K253407NeVa PV Thrombectomy DeviceVesalio, Inc.20250—
+5K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+5K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc.202411
+5K223791TalWireEmbrace Medical, Ltd.20230—
+5K221390BNLE Access GuidewireBiomerics Nle20230—
+5K223897Excipio LV Thrombectomy DeviceContego Medical, Inc.20231—
+5K210911WOLF Thrombectomy System, 14FDevoro Medical, Inc.20212—
+5K211081AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemAngioDynamics, Inc.20211—
+5K203476CAPERE Thrombectomy SystemVascular Medcure, Inc.20200—
+5K192935CAPERE Thrombectomy SystemVascular Medcure, Inc.20191—
+5K181694FlowTriever Retrieval/Aspiration SystemInari Medical20181—
+5K180329ClotTriever Thrombectomy SystemInari Medical, Inc.20184—
+5K133114Micropuncture Introducer SetCook Incorporated20144—
+6K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.20260—
+6K251485Excipio LV Prime Thrombectomy DeviceContego Medical, Inc.20250—
+6K221391WOLF Thrombectomy™ SmartClaw CatheterDevoro Medical, Inc.20221—
+6K213388AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemAngioDynamics, Inc.20220—
+6K201216CAPERE Thrombectomy SystemVascular Medcure, Inc.20200—
+6K182233FlowTriever Retrieval/Aspiration SystemInari Medical201801
+6K182531ClotTriever Thrombectomy SystemInari Medical20183—
+6K172980Micropuncture Pedal Access SetCook Incorporated20180—
+6K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated20172—
+7K253526NAMIC Dilator and SheathMedline Industries, LP20260—
+7K241207SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter…Devoro Medical, Inc.20240—
+7K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical20240—
+7K230743ICHOR 14F Embolectomy SystemIchor20230—
+7K192332ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever SheathInari Medical20190—
+7K192036ClotTriever Thrombectomy SystemInari Medical20190—