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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K181954
Device Name autoLog IQ Autotransfusion System
Applicant
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact Sue Fidler
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact Sue Fidler
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/23/2018
Decision Date 08/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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