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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 K123303
Device Name FEMORAL ACCESS VENOUS CANNULAE
Original Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy
draper,  UT  84020
Original Contact dannette crooms
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/23/2012
Decision Date 03/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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