510(k) Report

Devices descending from K021899

186 later devices reach Concentric Balloon Guide Catheter, Model 90072 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+5K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+5K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc.20153—
+5K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+5K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+5K121745Mantaray GuidewiresBridgepoint Medical20120—
+6K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+6K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+6K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro20260—
+6K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+6K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+6K251097V-DAC CatheterVesalio, Inc.20260—
+6K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—
+6K251014APRO 45 CatheterAlembic, LLC20251—
+6K250962APRO 55 Intermediate CatheterAlembic, LLC20250—
+6K243593AXS Lift Intracranial Base CatheterStryker Neurovascular20251—
+6K242051VersaD Delivery CatheterUnity Medical, Inc.20251—
+6K243297APRO 70 Swift CatheterAlembic, LLC20250—
+6K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+6K24097187 NeuGlide CatheterPiraeus Medical20242—
+6K240746Neurovascular Access System FamilyQ'Apel Medical, Inc.20240—
+6K2405298F Modified Sheath SystemRoute 92 Medical, Inc.20240—
+6K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20240—
+6K233924EMBOGUARD Balloon Guide CatheterNeuravi Limited20240—
+6K231056Esperance Distal Access CatheterWallaby Medical20240—
+6K231179Slinky CatheterAnoxia Medical, Inc.20230—
+6K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.20232—
+6K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+6K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+6K230322SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20230—
+6K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+6K221822BENCHMARK BMX81 Access SystemPenumbra, Inc.20222—
+6K214048Millipede 088 Access CatheterPerfuze, Ltd.20226—
+6K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+6K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+6K220716Spartan SC 069Spartan Micro, Inc.20220—
+6K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+6K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+6K201518Route 92 Medical 088 Access SystemRoute 92 Medical20205—
+6K190833AXS Vecta Aspiration CatheterStryker Neurovascular20196—
+6K193034AXS Infinity LS Plus Long SheathStryker Neurovascular20191—
+6K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc.20195—
+6K191664SelectFlex 072 Neurovascular Access SystemQ'Apel Medical20192—
+6K171672065 Zenith, 074 ZenithInneuroco, Inc.20171—
+6K161262Super Distal Access (SDA)Inneuroco, Inc.20160—
+6K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+7K26227770 NeuGlide CatheterPiraeus Medical, Inc.20260—
+7K262392APRO 35 Swift CatheterAlembic, LLC20260—
+7K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+7K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+7K253975Radical 6F Access CatheterMaduro Medical, Inc.20260—
+7K253032AXS Lift Intracranial Base CatheterStryker Neurovascular20260—
+7K251372VersaD Delivery CatheterUnity Medical, Inc.20250—
+7K25104493 NeuFlex CatheterPiraeus Medical20250—
+7K243577Radical the Dude 8F Guide CatheterMaduro Medical, Inc.20250—
+7K241637Echo Intracranial Base CatheterStryker Neurovascular20240—
+7K234074Next Generation Access CatheterBalt USA, LLC20241—
+7K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+7K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+7K231802Millipede 088 Access CatheterPerfuze, Ltd.20235—
+7K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.20231—
+7K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular20213—
+7K211893SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20211—
+7K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc.20213—
+7K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc.20200Class I
+7K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+7K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular20201—
+7K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc.20180—
+7K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+8K261176Zoom 4S CatheterImperative Care, Inc.20260—
+8K254223Next Generation 088 CatheterBalt USA, LLC20260—
+8K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—
+8K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+8K241768Broadway 8 CatheterStryker Neurovascular20240—
+8K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.20241—
+8K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+8K233648Millipede 088 Access CatheterPerfuze, Ltd.20234—
+8K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+8K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.20222Class I
+9K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—
+9K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+9K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+10K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—
+10K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+10K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+11K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—