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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K140208
Models DFEMII,DIIFEMII, DVFEM, DIIDVFEM, FEMII(A), FEMII(V), FTV, TFA, VFEM,LV
Device Name FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
Original Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy
draper,  UT  84020
Original Contact lindsay martin
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/03/2014
Decision Date 03/05/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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