510(k) Report

Devices descending from K132947

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142259Direxion Torqueable MicrocatheterBoston Scientific Corp20144—
+2K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation2017341
+3K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…Transit Scientific, LLC20230—
+3K201792TRUSELECT MicrocatheterBoston Scientific Corporation20201—
+4K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation20260—