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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 K900758
Device Name HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
Applicant
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact MARY L ARMSTRONG
Correspondent
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact MARY L ARMSTRONG
Regulation Number870.4260
Classification Product Code
DTM  
Date Received02/16/1990
Decision Date 05/17/1990
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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