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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K860775
Device Name MEDIASTINAL AUTOTRANSFUSION SYSTEM
Applicant
Cardio Metrics, Inc.
10415 Landsbury Dr.
Houston,  TX  77099
Applicant Contact MARY K NOONEN
Correspondent
Cardio Metrics, Inc.
10415 Landsbury Dr.
Houston,  TX  77099
Correspondent Contact MARY K NOONEN
Regulation Number870.4230
Classification Product Code
DTP  
Date Received03/03/1986
Decision Date 05/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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