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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 K120987
Model 91037
Device Name DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
Original Applicant
MEDTRONIC INC.
7611 northland drive
minneapolis,  MN  55428
Original Contact emily blus
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/02/2012
Decision Date 06/06/2012
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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