510(k) Report

Devices descending from K013789

81 later devices reach Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3Asahi Intecc Co., Ltd.20240—
+1K083343Headway 17 MicrocatheterMicroVention, Inc.200839—
+1K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp2004257
+1K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.200320—
+2K210601Plato 17 MicrocatheterScientia Vascular, LLC202111
+2K172014Wedge MicrocatheterMicroVention, Inc.20183—
+2K173548Merit Pursue MicrocatheterMerit Medical Systems, Inc.201801
+2K122684Reverse Medical MicrocatheterReverse Medical Corporation20122—
+2K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+2K120917Headway Duo MicrocatheterMicroVention, Inc.201212—
+2K113778Excelsior XT-27 MicrocatheterStryker Neurovascular201283
+2K101542Headway 17 Advanced MicrocatheterMicroVention, Inc.201031
+2K100826Penumbra Catherer 025Penumbra, Inc.20102—
+2K093160Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc.200919—
+2K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation20067—
+2K050630Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular200501
+2K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417—
+2K033726PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular20041—
+3K254071p17 XR MicrocatheterWallaby Medical20260—
+3K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…Stryker Neurovascular20250—
+3K232542Wedge XL Delivery CatheterMicroVention, Inc.20240—
+3K230609NG Delivery CatheterBalt USA, LLC20231—
+3K223560Plato 17 MicrocatheterScientia Vascular, Inc.202301
+3K203842Bendit21 MicrocatheterBend IT Technologies, Ltd.20221—
+3K182487CerusEndo MicrocatheterCerus Endovascular, Inc.20190—
+3K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+3K183045Eclipse 2LBalt USA, LLC20190—
+3K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—
+3K152840Lantern Delivery MicrocatheterPenumbra, Inc.20151—
+3K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+3K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.201331
+3K131482Sofia Distal Access CatheterMicroVention, Inc.201311—
+3K130858Reverse Medical MicrocatheterReverse Medical Corporation20131—
+3K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20134—
+3K110813Headway 27 MicrocatheterMicroVention, Inc.20118—
+3K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation20076—
+3K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+4K252213Bendit17 MicrocatheterBend IT Technologies, Ltd.20250—
+4K252569Carrier XL Delivery CatheterBalt USA, LLC20250—
+4K242033Access25™ Delivery MicrocatheterPenumbra, Inc.20240—
+4K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+4K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+4K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc.20192—
+4K171268Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20170—
+4K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.20164—
+4K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+4K142449Headway 27 MicrocatheterMicroVention, Inc.20155—
+4K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+4K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+4K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+4K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation20075—
+4K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+5K231179Slinky CatheterAnoxia Medical, Inc.20230—
+5K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+5K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+5K213314CerusEndo Microcatheter (027)Cerus Endovascular, Inc.20220—
+5K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.20220—
+5K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.20210—
+5K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+5K192625PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company20193—
+5K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20192—
+5K172716V2K Rinspiration SystemV2k Medical, Inc.20180—
+5K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+5K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+5K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+6K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+6K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+6K231600SENDERO MicrocatheterOkami Medical, Inc.20232—
+6K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+6K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20201—
+6K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+6K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+6K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+7K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+7K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+7K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+7K240384SENDERO MicrocatheterOkami Medical, Inc.20241—
+7K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—
+8K242644SENDERO MAX Delivery CatheterOkami Medical, Inc.20240—