510(k) Report

Devices descending from K083125

86 later devices reach Neuron Select Catheter Size 070 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142321Benchmark Intracranial Access SystemPenumbra, Inc.201516—
+1K111380Neuron Max SystemPenumbra, Inc.201161—
+1K100826Penumbra Catherer 025Penumbra, Inc.20102—
+1K093970Pica CatheterPenumbra, Inc.20105—
+2K253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited20260—
+2K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)Penumbra, Inc.20240—
+2K2226036F Wallaby Long SheathWallaby Medical, Inc.20230—
+2K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+2K212838Benchmark Intracranial Access SystemPenumbra, Inc.20227—
+2K201271Benchmark BMX96 Access SystemPenumbra, Inc.20201—
+2K200910BOSS Balloon Guide CatheterMarblehead Medical20201—
+2K200417RIST Radial Access CatheterRist Neurovascular, Inc.20203—
+2K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide…Medos International SARL20200Class I
+2K182918Ballast 088 Long SheathBalt USA, LLC20191—
+2K181000SelectFlex 072 Neurovascular Access SystemQ'Apel20183—
+2K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc.201827—
+2K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc.2016131
+2K151396MIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc.201512
+2K152840Lantern Delivery MicrocatheterPenumbra, Inc.20151—
+2K122772Penumbra DDC CathetersPenumbra, Inc.20124—
+3K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+3K243593AXS Lift Intracranial Base CatheterStryker Neurovascular20251—
+3K242376Next Generation Access PlatformBalt USA, LLC20240Class I
+3K242033Access25™ Delivery MicrocatheterPenumbra, Inc.20240—
+3K240746Neurovascular Access System FamilyQ'Apel Medical, Inc.20240—
+3K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+3K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+3K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+3K230322SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20230—
+3K221822BENCHMARK BMX81 Access SystemPenumbra, Inc.20222—
+3K213390Benchmark BMX96 Access SystemPenumbra, Inc.20220—
+3K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc.20216—
+3K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc.202117—
+3K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC20210—
+3K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+3K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc.20200—
+3K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc.20208—
+3K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc.20202—
+3K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc.20196—
+3K191664SelectFlex 072 Neurovascular Access SystemQ'Apel Medical20192—
+3K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.201721
+3K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc.20153—
+4K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+4K253032AXS Lift Intracranial Base CatheterStryker Neurovascular20260—
+4K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+4K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+4K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—
+4K242051VersaD Delivery CatheterUnity Medical, Inc.20251—
+4K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+4K24097187 NeuGlide CatheterPiraeus Medical20242—
+4K2405298F Modified Sheath SystemRoute 92 Medical, Inc.20240—
+4K234074Next Generation Access CatheterBalt USA, LLC20241—
+4K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.20232—
+4K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+4K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+4K214048Millipede 088 Access CatheterPerfuze, Ltd.20226—
+4K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+4K211893SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.20211—
+4K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+4K201518Route 92 Medical 088 Access SystemRoute 92 Medical20205—
+4K193034AXS Infinity LS Plus Long SheathStryker Neurovascular20191—
+4K171672065 Zenith, 074 ZenithInneuroco, Inc.20171—
+4K161262Super Distal Access (SDA)Inneuroco, Inc.20160—
+5K26227770 NeuGlide CatheterPiraeus Medical, Inc.20260—
+5K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+5K254223Next Generation 088 CatheterBalt USA, LLC20260—
+5K253975Radical 6F Access CatheterMaduro Medical, Inc.20260—
+5K251372VersaD Delivery CatheterUnity Medical, Inc.20250—
+5K25104493 NeuFlex CatheterPiraeus Medical20250—
+5K243577Radical the Dude 8F Guide CatheterMaduro Medical, Inc.20250—
+5K241637Echo Intracranial Base CatheterStryker Neurovascular20240—
+5K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+5K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+5K231802Millipede 088 Access CatheterPerfuze, Ltd.20235—
+5K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc.20213—
+5K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc.20200Class I
+5K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc.20180—
+6K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—
+6K233648Millipede 088 Access CatheterPerfuze, Ltd.20234—
+6K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.20222Class I
+7K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+7K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+8K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—
+8K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+8K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+9K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—