510(k) Report

Devices descending from K010004

6 later devices reach Flowrider Flow Directed Micro Catheter, Model 105-5065 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024118Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066Micro Therapeutics, Inc.200351
+2K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…Ev3, Inc.200932
+2K034036Marathon Flow Directed Micro Catheter, Model 105-5055Micro Therapeutics, Inc.200441
+3K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular20211—
+3K202318Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20200—
+4K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited20250—