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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 K133293
Device Name 15 FR. TANDEMHEART ARTERIAL CANNULA
Original Applicant
CARDIACASSIST INC.
240 alpha drive
pittsburgh,  PA  15238
Original Contact greg johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/28/2013
Decision Date 02/12/2014
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
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