510(k) Report

Devices descending from K193244

14 later devices reach Indigo Aspiration System – Lightning Aspiration Tubing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250787Liberant Thrombectomy SystemMedtronic, Ireland20250—
+1K210323Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc.202111—
+1K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc.20200—
+2K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20231—
+2K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+3K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+3K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingPenumbra, Inc.20240—
+3K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+3K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+3K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+4K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+4K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+4K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+4K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—