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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 K120988
Model 66112-66140 AND CB66112- CB66140, 67512-67540 AND CB67512 - CB67540, 67312- 67530 AND CB67312 - CB67530, 68112-68140 AND
Device Name DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
Original Applicant
MEDTRONIC INC.
7611 northland drive
minneapolis,  MN  55428
Original Contact jacqueline hauge
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/02/2012
Decision Date 07/25/2012
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
Recalls CDRH Recalls
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