510(k) Report

Devices descending from K122756

45 later devices reach Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243638MV Flow Aspiration Pump (MVFLOWPMP01)Microvention20250—
+1K243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20240—
+1K232831Quiver Aspiration PumpAnoxia Medical, Inc.20240—
+1K233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,Ltd20230—
+1K180115TWBM PumpTaiwan Biomaterial Co., Ltd.20181—
+1K181398DV-300 AspiratorDing Hwa Co., Ltd.20180—
+1K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.201631—
+1K132931Apollo SystemPenumbra, Inc.20145—
+2K190105ZOOM Aspiration PumpTaiwan Biomaterial Co., Ltd.20190—
+2K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…Stryker20186—
+2K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20173—
+2K171332Artemis Neuro Evacuation DevicePenumbra, Inc.20172—
+2K162901Penumbra 3D Revascularization DevicePenumbra, Inc.201716Class I
+2K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201617—
+2K152699Apollo SystemPenumbra, Inc.20164—
+3K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.20260—
+3K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited20260—
+3K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC20244—
+3K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.202101
+3K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.202121
+3K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical20201—
+3K201689Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20201—
+3K190464Penumbra System 3D Revascularization DevicePenumbra, Inc.20190—
+3K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker20190—
+3K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+3K181731MR Compatible Aspiration KitMri Interventions, Inc.20180—
+3K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+3K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.201810—
+3K180008Penumbra SystemPenumbra, Inc.20180—
+4K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+4K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.20260—
+4K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC20251—
+4K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+4K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+4K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20240—
+4K230125Neuroblade SystemClearmind Biomedical20230—
+4K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.20221—
+4K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20213—
+4K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.20193Class I
+5K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20260—
+5K251006NeVasc Aspiration SystemVesalio, Inc.20250—
+5K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20251—
+5K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+5K191946Penumbra System Penumbra JET 7XPenumbra, Inc.20202Class I
+6K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I