510(k) Report

Devices descending from K160449

31 later devices reach Penumbra System, Penumbra Pump MAX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…Stryker20186—
+1K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20173—
+1K162901Penumbra 3D Revascularization DevicePenumbra, Inc.201716Class I
+1K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201617—
+2K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.20260—
+2K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited20260—
+2K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC20244—
+2K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.202101
+2K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.202121
+2K201689Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20201—
+2K190464Penumbra System 3D Revascularization DevicePenumbra, Inc.20190—
+2K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker20190—
+2K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+2K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+2K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.201810—
+2K180008Penumbra SystemPenumbra, Inc.20180—
+3K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+3K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.20260—
+3K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC20251—
+3K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+3K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+3K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20240—
+3K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.20221—
+3K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20213—
+3K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.20193Class I
+4K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20260—
+4K251006NeVasc Aspiration SystemVesalio, Inc.20250—
+4K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20251—
+4K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+4K191946Penumbra System Penumbra JET 7XPenumbra, Inc.20202Class I
+5K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I