510(k) Report

Devices descending from K121917

43 later devices reach Penumbra Embolectomy Aspiration System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc.201542—
+2K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc.20260—
+2K250787Liberant Thrombectomy SystemMedtronic, Ireland20250—
+2K230030Excipio SV Aspiration Catheter and TubingContego Medical, Inc.20230—
+2K223216Symphony Thrombectomy SystemTruvic Medical, Inc.20233—
+2K214114Prodigy Thrombectomy SystemTruvic Medical, Inc.20220—
+2K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc.20201—
+2K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Penumbra, Inc.202012—
+2K192833Indigo Aspiration SystemPenumbra, Inc.20195—
+2K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.201627—
+3K251070Akura Thrombectomy SystemAkura Medical20250—
+3K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20252—
+3K242319Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc.20240—
+3K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+3K220270Aspirex Thrombectomy SystemC.R. Bard, Inc.20221—
+3K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7Penumbra, Inc.20210—
+3K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200—
+3K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc.20200—
+3K161523INDIGO Aspiration SystemPenumbra, Inc.201626—
+4K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+4K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20251—
+4K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+4K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+4K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+4K230356Aspirex™ Thrombectomy SystemC.R. Bard, Inc.20230—
+4K213771Merlin Aspiration SystemMivi Neurovascular, Inc.20220—
+4K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra…Penumbra, Inc.201822—
+5K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+5K261523Vertex™ Thrombectomy SystemJupiter Endovascular20260—
+5K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+5K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+5K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—
+5K180939Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc.201821—
+6K234073ICE Aspiration SystemExpanse Medical, Inc.20242—
+6K193197QuickClear Mechanical Thrombectomy SystemVolcano Atheromed, Inc.20202—
+6K193244Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc.202014—
+7K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation20260—
+7K251312Vesalio Peripheral SystemVesalio, Inc.20250—
+7K251488FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20251—
+7K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc.202111—
+8K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.20260—
+8K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20231—
+9K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20240—