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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 K031700
Device Name MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
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  
Subsequent Product Code
DTL  
Date Received06/02/2003
Decision Date 08/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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