510(k) Report

Devices descending from K033463

5 later devices reach Edwards Lifesciences Research Medical Pediatric Arterial Cannulae through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123298Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC201324
+1K123370EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion…Edwards Lifesciences, LLC201314
+2K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…Edwards Lifesciences20240—
+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—