510(k) Report

Devices descending from K042040

6 later devices reach Triactiv System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060651Proxis System, Model EPS101St Jude Medical20063—
+1K061772Triactiv FX Embolic Protection SystemKensey Nash Corp.200613
+2K073563Modification to Proxis SystemSt Jude Medical20080—
+2K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+2K062870Triactiv FX Embolic Protection System, Model PN 60040-02; -03Kensey Nash Corp.20060—
+3K0737006F Proxis SystemSt. Jude Medical, Inc.20080—