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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 K012538
Device Name TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
Original Applicant
MEDTRONIC VASCULAR
7611 northland dr.
minneapolis,  MN  55428
Original Contact marie holm
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/07/2001
Decision Date 08/23/2001
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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