510(k) Report

Devices descending from K031610

13 later devices reach Rex Medical Cleaner Rotational Thrombectomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P.200610—
+1K040252Cleaner Rotational Thrombectomy System KitRex Medical200411—
+1K033793Cleaner II Rotational Thrombectomy SystemRex Medical200312—
+2K120346Cleaner Rotational Thrombectomy SystemRex Medical20128—
+2K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical20109—
+3K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+4K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+4K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+5K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+5K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+5K223891Cobra Catheter SystemEndovascular Engineering20232—
+6K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+7K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—