510(k) Report

Devices descending from K163701

3 later devices reach Direxion and Direxion HI-FLO Torqueable Microcatheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…Transit Scientific, LLC20230—
+1K201792TRUSELECT MicrocatheterBoston Scientific Corporation20201—
+2K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation20260—