510(k) Report

Devices descending from K161523

26 later devices reach INDIGO Aspiration System through their predicates, nearest generation first.

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