510(k) Report

Devices descending from K003410

165 later devices reach Concentric Retriever, Model 90030 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.20260—
+8K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.20260—
+8K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+8K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20251—
+8K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+8K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+8K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC20244—
+8K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+8K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+8K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+8K230356Aspirex™ Thrombectomy SystemC.R. Bard, Inc.20230—
+8K223305Trevo NXT ProVue RetrieverStryker Neurovascular202301
+8K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+8K213771Merlin Aspiration SystemMivi Neurovascular, Inc.20220—
+8K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.202101
+8K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.202121
+8K203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20210—
+8K201689Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20201—
+8K190464Penumbra System 3D Revascularization DevicePenumbra, Inc.20190—
+8K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker20190—
+8K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+8K181354074 Zenith Flex SystemInneuroco, Inc.201861
+8K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.201810—
+8K180008Penumbra SystemPenumbra, Inc.20180—
+8K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc.201822—
+9K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+9K261523Vertex™ Thrombectomy SystemJupiter Endovascular20260—
+9K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+9K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.20260—
+9K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+9K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+9K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—
+9K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+9K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC20251—
+9K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+9K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+9K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+9K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20240—
+9K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.20221—
+9K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20213—
+9K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.20193Class I
+9K190212AXS Vecta Aspiration SystemStryker Neurovascular20195—
+9K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.201821—
+10K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20260—
+10K251006NeVasc Aspiration SystemVesalio, Inc.20250—
+10K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—
+10K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20251—
+10K234073ICE Aspiration SystemExpanse Medical, Inc.20242—
+10K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+10K193197QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc.20202—
+10K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc.202014—
+10K191946Penumbra System Penumbra JET 7XPenumbra, Inc.20202Class I
+10K191768AXS Vecta Aspiration SystemStryker Neurovascular20194—
+11K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration…Maduro Medical, Inc.20260—
+11K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation20260—
+11K251312Vesalio Peripheral SystemVesalio, Inc.20250—
+11K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20251—
+11K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20252—
+11K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I
+11K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc.202111—
+12K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20260—
+12K253590Millipede SystemPerfuze, Ltd.20261—
+12K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20231—
+13K262399Millipede SystemPerfuze, Ltd.20260—
+13K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20240—