510(k) Report

Devices descending from K123298

2 later devices reach Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC20141Class I
+2K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC20200—