510(k) Report

Devices descending from K072718

120 later devices reach Penumbra System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—
+7K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20251—
+7K234073ICE Aspiration SystemExpanse Medical, Inc.20242—
+7K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+7K193197QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc.20202—
+7K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc.202014—
+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—
+8K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation20260—
+8K251312Vesalio Peripheral SystemVesalio, Inc.20250—
+8K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20251—
+8K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20252—
+8K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I
+8K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc.202111—
+9K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20260—
+9K253590Millipede SystemPerfuze, Ltd.20261—
+9K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20231—
+10K262399Millipede SystemPerfuze, Ltd.20260—
+10K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20240—