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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 K132451
Model 39 MODEL NUMBERS
Device Name SARNS SOFT-FLOW AORTIC 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 Received08/12/2013
Decision Date 02/18/2014
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 Yes
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