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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 K063618
Device Name TENDERFLOW PERIATRIC ARTERIAL CANNULA
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor,  MI  48103
Original Contact christina l thomas
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/05/2006
Decision Date 03/13/2007
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
Recalls CDRH Recalls
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