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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 K051303
Device Name BIO-CONSOLE, MODEL 560
Applicant
Medtronic Perfusion Systems
7611 Northland Dr. N
Brooklyn Park,  MN  55428
Applicant Contact DAWN M STENSTROM
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr. N
Brooklyn Park,  MN  55428
Correspondent Contact DAWN M STENSTROM
Regulation Number870.4380
Classification Product Code
DWA  
Date Received05/19/2005
Decision Date 06/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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