510(k) Report

Devices descending from K111380

61 later devices reach Neuron Max System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited20260—
+1K2226036F Wallaby Long SheathWallaby Medical, Inc.20230—
+1K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+1K201271Benchmark BMX96 Access SystemPenumbra, Inc.20201—
+1K200910BOSS Balloon Guide CatheterMarblehead Medical20201—
+1K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide…Medos International SARL20200Class I
+1K182918Ballast 088 Long SheathBalt USA, LLC20191—
+1K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc.201827—
+1K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc.2016131
+1K151396MIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc.201512
+2K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+2K242376Next Generation Access PlatformBalt USA, LLC20240Class I
+2K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+2K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+2K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+2K213390Benchmark BMX96 Access SystemPenumbra, Inc.20220—
+2K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc.20216—
+2K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc.202117—
+2K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC20210—
+2K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc.20200—
+2K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc.20208—
+2K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc.20202—
+2K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc.20196—
+2K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.201721
+3K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+3K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+3K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+3K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—
+3K242051VersaD Delivery CatheterUnity Medical, Inc.20251—
+3K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+3K24097187 NeuGlide CatheterPiraeus Medical20242—
+3K2405298F Modified Sheath SystemRoute 92 Medical, Inc.20240—
+3K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.20232—
+3K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.20231—
+3K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20232—
+3K214048Millipede 088 Access CatheterPerfuze, Ltd.20226—
+3K220807Imperative Care Radial 088 Access SystemImperative Care, Inc.20220—
+3K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+3K201518Route 92 Medical 088 Access SystemRoute 92 Medical20205—
+3K193034AXS Infinity LS Plus Long SheathStryker Neurovascular20191—
+4K26227770 NeuGlide CatheterPiraeus Medical, Inc.20260—
+4K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+4K253975Radical 6F Access CatheterMaduro Medical, Inc.20260—
+4K251372VersaD Delivery CatheterUnity Medical, Inc.20250—
+4K25104493 NeuFlex CatheterPiraeus Medical20250—
+4K243577Radical the Dude 8F Guide CatheterMaduro Medical, Inc.20250—
+4K241637Echo Intracranial Base CatheterStryker Neurovascular20240—
+4K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…Imperative Care, Inc.20241—
+4K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc.20240—
+4K231802Millipede 088 Access CatheterPerfuze, Ltd.20235—
+4K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc.20213—
+4K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc.20200Class I
+5K252297Toro 88 Superbore CatheterToro Neurovascular, Inc.20260—
+5K233648Millipede 088 Access CatheterPerfuze, Ltd.20234—
+5K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.20222Class I
+6K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+6K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+7K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—
+7K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+7K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+8K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—