510(k) Report

Devices descending from K091029

9 later devices reach Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+1K120346Cleaner Rotational Thrombectomy SystemRex Medical20128—
+2K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+2K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+3K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+3K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+3K223891Cobra Catheter SystemEndovascular Engineering20232—
+4K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+5K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—