510(k) Report

Devices descending from K003086

130 later devices reach Concentric Micro Catheter, Models 90001 to 90008 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+7K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20250—
+7K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20240—
+7K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.20221—
+7K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20213—
+7K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.20193Class I
+7K190212AXS Vecta Aspiration SystemStryker Neurovascular20195—
+7K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.201821—
+8K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC20260—
+8K251006NeVasc Aspiration SystemVesalio, Inc.20250—
+8K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—
+8K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20251—
+8K234073ICE Aspiration SystemExpanse Medical, Inc.20242—
+8K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+8K193197QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc.20202—
+8K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc.202014—
+8K191946Penumbra System Penumbra JET 7XPenumbra, Inc.20202Class I
+8K191768AXS Vecta Aspiration SystemStryker Neurovascular20194—
+9K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration…Maduro Medical, Inc.20260—
+9K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation20260—
+9K251312Vesalio Peripheral SystemVesalio, Inc.20250—
+9K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20251—
+9K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20252—
+9K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I
+9K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc.202111—
+10K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20260—
+10K253590Millipede SystemPerfuze, Ltd.20261—
+10K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20231—
+11K262399Millipede SystemPerfuze, Ltd.20260—
+11K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20240—