510(k) Report

Devices descending from K072718

120 later devices reach Penumbra System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142458Penumbra System ACEPenumbra, Inc.201560—
+1K133317Penumbra System / Penumbra System MaxPenumbra, Inc.201461—
+1K122772Penumbra DDC CathetersPenumbra, Inc.20124—
+1K121917Penumbra Embolectomy Aspiration SystemPenumbra, Inc.201243—
+1K113163Penumbra System MaxPenumbra, Inc.2011116—
+1K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Penumbra, Inc.2010118—
+1K093970Pica CatheterPenumbra, Inc.20105—
+2K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited20260—
+2K240917Esperance 3+ Aspiration Catheter SystemWallaby Medical20240—
+2K223913Socrates Aspiration SystemScientia Vascular, Inc.202301
+2K223545APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20231—
+2K211697Esperance Aspiration Catheter SystemWallaby Medical20211—
+2K190338046 Zenith FlexInneuroco, Inc.20193—
+2K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.201654—
+2K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc.20153—
+2K151623Penumbra System 110 Aspiration TubingPenumbra, Inc.20152—
+2K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc.201542—
+3K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc.20260—
+3K251357Esperance pHLO Aspiration SystemPhenox, Ltd.20260—
+3K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc.20250—
+3K250787Liberant Thrombectomy SystemMedtronic, Ireland20250—
+3K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…Cerenovus, Inc.20241—
+3K230030Excipio SV Aspiration Catheter and TubingContego Medical, Inc.20230—
+3K230695APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20230—
+3K223216Symphony Thrombectomy SystemTruvic Medical, Inc.20233—
+3K214114Prodigy Thrombectomy SystemTruvic Medical, Inc.20220—
+3K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc.20201—
+3K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Penumbra, Inc.202012—
+3K192833Indigo Aspiration SystemPenumbra, Inc.20195—
+3K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+3K173200SOFIA Plus Aspiration CatheterMicroVention, Inc.20185—
+3K171672065 Zenith, 074 ZenithInneuroco, Inc.20171—
+3K161262Super Distal Access (SDA)Inneuroco, Inc.20160—
+3K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201615—
+3K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.201631—
+3K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.201627—
+4K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—
+4K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+4K251070Akura Thrombectomy SystemAkura Medical20250—
+4K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20252—
+4K242319Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc.20240—
+4K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20234—
+4K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20230Class I
+4K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+4K220270Aspirex Thrombectomy SystemC.R. Bard, Inc.20221—
+4K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7Penumbra, Inc.20210—
+4K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200—
+4K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+4K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc.20200—
+4K182101Riptide Aspiration System (React 71 Catheter)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+4K180705Riptide Aspiration System React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20181—
+4K172167Zenith Flex SystemInneuroco, Inc.201871
+4K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…Stryker20186—
+4K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc.20180—
+4K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20173—
+4K162901Penumbra 3D Revascularization DevicePenumbra, Inc.201716Class I
+4K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201617—
+4K161523INDIGO Aspiration SystemPenumbra, Inc.201626—
+5K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.20260—
+5K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+5K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20251—
+5K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+5K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+5K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC20244—
+5K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+5K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+5K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+5K230356Aspirex™ Thrombectomy SystemC.R. Bard, Inc.20230—
+5K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+5K213771Merlin Aspiration SystemMivi Neurovascular, Inc.20220—
+5K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.202101
+5K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.202121
+5K201689Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20201—
+5K190464Penumbra System 3D Revascularization DevicePenumbra, Inc.20190—
+5K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker20190—
+5K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+5K181354074 Zenith Flex SystemInneuroco, Inc.201861
+5K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.201810—
+5K180008Penumbra SystemPenumbra, Inc.20180—
+5K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc.201822—
+6K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+6K261523Vertex™ Thrombectomy SystemJupiter Endovascular20260—
+6K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+6K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.20260—
+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—
+6K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—
+6K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+6K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC20251—
+6K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+6K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+6K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+6K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20240—
+6K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.20221—
+6K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20213—
+6K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.20193Class I
+6K190212AXS Vecta Aspiration SystemStryker Neurovascular20195—
+6K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.201821—
+7K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20260—
+7K251006NeVasc Aspiration SystemVesalio, Inc.20250—