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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, Cardiopulmonary Bypass, Arterial Line
510(k) Number K851003
Device Name ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
Applicant
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Applicant Contact WENDELL V EBLING
Correspondent
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Correspondent Contact WENDELL V EBLING
Regulation Number870.4260
Classification Product Code
DTM  
Date Received03/12/1985
Decision Date 07/29/1985
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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