510(k) Report

Devices descending from K133317

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151623Penumbra System 110 Aspiration TubingPenumbra, Inc.20152—
+1K142458Penumbra System ACEPenumbra, Inc.201560—
+2K223545APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20231—
+2K211697Esperance Aspiration Catheter SystemWallaby Medical20211—
+2K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+2K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.201654—
+3K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+3K251357Esperance pHLO Aspiration SystemPhenox, Ltd.20260—
+3K230695APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20230—
+3K173200SOFIA Plus Aspiration CatheterMicroVention, Inc.20185—
+3K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201615—
+3K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.201631—
+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
+4K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+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—
+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—
+5K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.20260—
+5K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited20260—
+5K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+5K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC20244—
+5K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+5K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+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—
+6K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+6K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.20260—
+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—
+7K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20260—
+7K251006NeVasc Aspiration SystemVesalio, Inc.20250—
+7K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—
+7K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20251—
+7K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+7K191946Penumbra System Penumbra JET 7XPenumbra, Inc.20202Class I
+7K191768AXS Vecta Aspiration SystemStryker Neurovascular20194—
+8K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration…Maduro Medical, Inc.20260—
+8K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20252—
+8K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I
+9K253590Millipede SystemPerfuze, Ltd.20261—
+10K262399Millipede SystemPerfuze, Ltd.20260—