510(k) Report

Devices descending from K994155

120 later devices reach Excelsior 1018 Microcatheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123452Tracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft, Tracker-17…Stryker20131—
+1K050599Tracker Excel -14 Pre-Shaped MicrocatheterBoston Scientific Corp200535—
+1K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp2004257
+1K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target2001812
+2K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3Asahi Intecc Co., Ltd.20240—
+2K210601Plato 17 MicrocatheterScientia Vascular, LLC202111
+2K173548Merit Pursue MicrocatheterMerit Medical Systems, Inc.201801
+2K142565Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17…Stryker Neurovascular20140—
+2K113778Excelsior XT-27 MicrocatheterStryker Neurovascular201283
+2K101542Headway 17 Advanced MicrocatheterMicroVention, Inc.201031
+2K100826Penumbra Catherer 025Penumbra, Inc.20102—
+2K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.200933—
+2K083343Headway 17 MicrocatheterMicroVention, Inc.200839—
+2K062885Stride MicrocatheterAsahi Intecc Co., Ltd.200734—
+2K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation20067—
+2K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.200320—
+3K254071p17 XR MicrocatheterWallaby Medical20260—
+3K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…Stryker Neurovascular20250—
+3K223560Plato 17 MicrocatheterScientia Vascular, Inc.202301
+3K172014Wedge MicrocatheterMicroVention, Inc.20183—
+3K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd.20187—
+3K171176M-CATH MicrocatheterAcrostak (Schweiz) AG20170—
+3K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—
+3K161126ASAHI Corsair ProAsahi Intecc Co., Ltd.201611—
+3K152840Lantern Delivery MicrocatheterPenumbra, Inc.20151—
+3K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd.201520—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.201331
+3K130858Reverse Medical MicrocatheterReverse Medical Corporation20131—
+3K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20134—
+3K122684Reverse Medical MicrocatheterReverse Medical Corporation20122—
+3K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+3K120917Headway Duo MicrocatheterMicroVention, Inc.201212—
+3K112035Valet Micro CatheterVolcano Corporation20129—
+3K093160Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc.200919—
+3K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation20076—
+3K050630Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular200501
+3K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417—
+3K033726PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular20041—
+4K242033Access25™ Delivery MicrocatheterPenumbra, Inc.20240—
+4K232542Wedge XL Delivery CatheterMicroVention, Inc.20240—
+4K230609NG Delivery CatheterBalt USA, LLC20231—
+4K203842Bendit21 MicrocatheterBend IT Technologies, Ltd.20221—
+4K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC20221—
+4K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC20220—
+4K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd.20210—
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K192599ASAHI PTCA Guide Wire ASAHI Gaia NextAsahi Intecc Co., Ltd.20200—
+4K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+4K182487CerusEndo MicrocatheterCerus Endovascular, Inc.20190—
+4K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+4K183045Eclipse 2LBalt USA, LLC20190—
+4K182420ASAHI Corsair Pro XSAsahi Intecc Co., Ltd.20180—
+4K182360Teleport MicrocatheterOrbusneich Medical Trading, Inc.20182—
+4K170664Odyssey Micro CatheterHeraeus Medical Components, LLC20170—
+4K171268Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20170—
+4K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.20164—
+4K152249ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20163—
+4K152447ASAHI CaravelAsahi Intecc Co., Ltd.20162—
+4K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+4K143744MicroCross CatheterRoxwood Medical, Inc.20151—
+4K141649Spex Support CatheterReflow Medical20146—
+4K131482Sofia Distal Access CatheterMicroVention, Inc.201311—
+4K110813Headway 27 MicrocatheterMicroVention, Inc.20118—
+4K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation20075—
+4K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+5K252213Bendit17 MicrocatheterBend IT Technologies, Ltd.20250—
+5K252569Carrier XL Delivery CatheterBalt USA, LLC20250—
+5K231608Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20241—
+5K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC20220—
+5K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+5K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.20220—
+5K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.20210—
+5K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20192—
+5K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc.20192—
+5K173560MicrocatheterSurmodics,Inc.20181—
+5K173662speX Support CatheterReflow Medical, Inc.20175—
+5K161362ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20162—
+5K151082MicroCross CatheterRoxwood Medical, Inc.20150—
+5K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+5K142449Headway 27 MicrocatheterMicroVention, Inc.20155—
+5K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+5K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+5K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+5K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+5K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+6K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd.20250—
+6K231179Slinky CatheterAnoxia Medical, Inc.20230—
+6K232647MicrocatheterSurmodics,Inc.20230—
+6K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+6K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+6K213314CerusEndo Microcatheter (027)Cerus Endovascular, Inc.20220—
+6K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+6K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18…Asahi Intecc Co., Ltd.20200—
+6K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20201—
+6K200094speX LP Support CatheterReflow Medical20201—
+6K193012speX Support CatheterReflow Medical20202—
+6K192782ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd.20190—
+6K192625PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company20193—
+6K172716V2K Rinspiration SystemV2k Medical, Inc.20180—