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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
510(k) Number K890504
Device Name CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
Applicant
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Applicant Contact LORI GLASTETTER
Correspondent
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Correspondent Contact LORI GLASTETTER
Regulation Number870.4270
Classification Product Code
JOD  
Date Received02/01/1989
Decision Date 03/10/1989
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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