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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reservoir, blood, cardiopulmonary bypass
510(k) Number K021287
Device Name TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55038
Applicant Contact PREETI JAIN
Correspondent
MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55038
Correspondent Contact PREETI JAIN
Regulation Number870.4400
Classification Product Code
DTN  
Date Received04/23/2002
Decision Date 05/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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