510(k) Report

Devices descending from K160533

27 later devices reach Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161523INDIGO Aspiration SystemPenumbra, Inc.201626—
+2K213771Merlin Aspiration SystemMivi Neurovascular, Inc.20220—
+2K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc.20201—
+2K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc.201822—
+3K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7Penumbra, Inc.20210—
+3K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.201821—
+4K234073ICE Aspiration SystemExpanse Medical, Inc.20242—
+4K193197QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc.20202—
+4K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc.202014—
+5K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation20260—
+5K251312Vesalio Peripheral SystemVesalio, Inc.20250—
+5K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20251—
+5K250787Liberant Thrombectomy SystemMedtronic, Ireland20250—
+5K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc.202111—
+5K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc.20200—
+6K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20260—
+6K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20231—
+6K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+7K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+7K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20240—
+7K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+7K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+7K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+8K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+8K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+8K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+8K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—