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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 K120780
Device Name EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy.
draper,  UT  84020
Contact dannette crooms
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/14/2012
Decision Date 06/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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