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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 K133151
Device Name SARNS HIGH FLOW AORTIC ARCH CANNULA
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton,  MD  21921
Original Contact garry a courtney
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/07/2013
Decision Date 02/03/2014
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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