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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sucker, Cardiotomy Return, Cardiopulmonary Bypass
510(k) Number K905008
Device Name FLEXIBLE INTRACARDIAC SUCTION DEVICE
Applicant
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Applicant Contact DEBI KRIDNER
Correspondent
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Correspondent Contact DEBI KRIDNER
Regulation Number870.4420
Classification Product Code
DTS  
Date Received11/06/1990
Decision Date 01/23/1991
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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