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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K080824
Device Name BIO-CONSOLE 560
Applicant
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55432
Applicant Contact PREETI JAIN
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55432
Correspondent Contact PREETI JAIN
Regulation Number870.4380
Classification Product Code
DWA  
Date Received03/24/2008
Decision Date 05/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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