510(k) Report

Devices descending from K891576

16 later devices reach Fem-Flex Femoral Access Cannulation Set 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
+1K052081Remote Access Perfusion (Rap) Femoral Venous CannulaEstech, Inc.200581
+1K991541A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44A-Med Systems, Inc.19990—
+1K974259Venous Flex II Peripheral and Intra-Operative Access Venous Return CannulaeEdwards Lifesciences Research Medical19983—
+1K972993Chase Femoral Access Cannulation SetChase Medical, Inc.19980—
+2K250283RAP Femoral Venous CannulaeLivaNova USA, Inc.20250—
+2K140208Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-FlexiiEdwards Lifesciences, LLC20141Class I
+2K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091—
+2K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc.20066—
+3K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.20250—
+3K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC20200—
+3K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+5K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+5K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—