510(k) Report

Devices descending from K010954

187 later devices reach Concentric Balloon Guide Catheter, Model 90031 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200417RIST Radial Access CatheterRist Neurovascular, Inc.20203—
+6K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc.20208—
+6K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+6K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc.20202—
+6K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc.20196—
+6K190833AXS Vecta Aspiration CatheterStryker Neurovascular20196—
+6K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc.20195—
+6K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc.20192—
+6K183357XableCath Crossing CatheterXablecath, Inc.20190—
+6K181000SelectFlex 072 Neurovascular Access SystemQ'Apel20183—
+6K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.201721
+6K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+6K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+6K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+6K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc.20153—
+6K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+6K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+6K121745Mantaray GuidewiresBridgepoint Medical20120—
+7K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+7K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+7K262392APRO 35 Swift CatheterAlembic, LLC20260—
+7K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+7K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+7K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—
+7K243593AXS Lift Intracranial Base CatheterStryker Neurovascular20251—
+7K242051VersaD Delivery CatheterUnity Medical, Inc.20251—
+7K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+7K24097187 NeuGlide CatheterPiraeus Medical20242—
+7K240746Neurovascular Access System FamilyQ'Apel Medical, Inc.20240—
+7K2405298F Modified Sheath SystemRoute 92 Medical, Inc.20240—
+7K231179Slinky CatheterAnoxia Medical, Inc.20230—
+7K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.20232—
+7K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+7K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+7K230322SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20230—
+7K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+7K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.20231—
+7K221822BENCHMARK BMX81 Access SystemPenumbra, Inc.20222—
+7K214048Millipede 088 Access CatheterPerfuze, Ltd.20226—
+7K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+7K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+7K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular20213—
+7K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+7K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+7K201518Route 92 Medical 088 Access SystemRoute 92 Medical20205—
+7K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+7K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular20201—
+7K193034AXS Infinity LS Plus Long SheathStryker Neurovascular20191—
+7K191664SelectFlex 072 Neurovascular Access SystemQ'Apel Medical20192—
+7K171672065 Zenith, 074 ZenithInneuroco, Inc.20171—
+7K161262Super Distal Access (SDA)Inneuroco, Inc.20160—
+7K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+8K26227770 NeuGlide CatheterPiraeus Medical, Inc.20260—
+8K261176Zoom 4S CatheterImperative Care, Inc.20260—
+8K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+8K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+8K253975Radical 6F Access CatheterMaduro Medical, Inc.20260—
+8K253032AXS Lift Intracranial Base CatheterStryker Neurovascular20260—
+8K251372VersaD Delivery CatheterUnity Medical, Inc.20250—
+8K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+8K25104493 NeuFlex CatheterPiraeus Medical20250—
+8K243577Radical the Dude 8F Guide CatheterMaduro Medical, Inc.20250—
+8K241637Echo Intracranial Base CatheterStryker Neurovascular20240—
+8K241768Broadway 8 CatheterStryker Neurovascular20240—
+8K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.20241—
+8K234074Next Generation Access CatheterBalt USA, LLC20241—
+8K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+8K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+8K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+8K231802Millipede 088 Access CatheterPerfuze, Ltd.20235—
+8K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+8K211893SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20211—
+8K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc.20213—
+8K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc.20200Class I
+8K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc.20180—
+8K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+9K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—
+9K254223Next Generation 088 CatheterBalt USA, LLC20260—
+9K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—
+9K233648Millipede 088 Access CatheterPerfuze, Ltd.20234—
+9K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.20222Class I
+10K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+10K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+11K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—
+11K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+11K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+12K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—