510(k) Report

Devices descending from K192981

12 later devices reach Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251070Akura Thrombectomy SystemAkura Medical20250—
+1K250787Liberant Thrombectomy SystemMedtronic, Ireland20250—
+1K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+1K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200—
+2K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+2K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+2K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+2K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+3K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+3K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20260—
+3K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.20260—
+3K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…Penumbra, Inc.20250—