510(k) Report

Devices descending from K100892

7 later devices reach Renegade HI-Flo Fathom Kit Model M001182XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140329Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom KitBoston Scientific20140—
+1K132947Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp20135—
+2K142259Direxion Torqueable MicrocatheterBoston Scientific Corp20144—
+3K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation2017341
+4K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…Transit Scientific, LLC20230—
+4K201792TRUSELECT MicrocatheterBoston Scientific Corporation20201—
+5K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation20260—