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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 14 Results
ProductCode: DWF Applicant: EDWARDS LIFESCIENCES, LLC Decision Date To: 04/28/2016
 
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ferm-flex and fem-flex ii ( femoral access arterial cannulae) femtrak,vfem, and fem-flexii EDWARDS LIFESCIENCES, LLC. K140208 03/05/2014
femoral access venous cannulae EDWARDS LIFESCIENCES, LLC. K123303 03/22/2013
fem-felx, fex-flex ii femoral access cannula with duraflo coating EDWARDS LIFESCIENCES, LLC. K123298 03/15/2013
ez glide aortic cannula, aortic perfusion cannula with duraflo coating, dispersion aortic perfusion cannula EDWARDS LIFESCIENCES, LLC. K123370 03/13/2013
retrograde coronary sinus cardioplegia catheter, retrograde cardioplegia catheter, retrograde cardioplegia cannula EDWARDS LIFESCIENCES, LLC. K123187 02/22/2013
anteplegia catheter antegrade cardioplegia catheter aortic root cannula antegrade catheter with duraflo coating EDWARDS LIFESCIENCES, LLC. K113459 06/29/2012
edward proplege peripheral retrograde cardioplegia device EDWARDS LIFESCIENCES, LLC. K120780 06/27/2012
edward vent catheters edward vent catheters with duraflo coating dispersion aortic perfusion cannula EDWARDS LIFESCIENCES, LLC. K113411 06/11/2012
venous drainage cannula with duraflo coating EDWARDS LIFESCIENCES, LLC. K120072 05/08/2012
embol-x access device/ aortic cannula, embol-x slim accessdevice/ aortic cannula, embol-x glide access device/ aortic ca EDWARDS LIFESCIENCES, LLC. K102420 10/26/2010
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