510(k) Report

Devices descending from K905312

4 later devices reach Duraflo II Heparin Treated Femoral Cannulae Models through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123303Femoral Access Venous CannulaeEdwards Lifesciences, LLC20132—
+1K123298Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC201324
+2K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC20141Class I
+3K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC20200—