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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K992592
Device Name A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
Applicant
A-Med Systems, Inc.
2491 Boatman Ave.
West Sacramento,  CA  95691
Applicant Contact ROBERTA THOMPSON
Correspondent
A-Med Systems, Inc.
2491 Boatman Ave.
West Sacramento,  CA  95691
Correspondent Contact ROBERTA THOMPSON
Regulation Number870.4360
Classification Product Code
KFM  
Subsequent Product Code
DTQ  
Date Received08/02/1999
Decision Date 05/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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