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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K871221
Device Name CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
Applicant
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Applicant Contact STEVEN ARICK
Correspondent
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Correspondent Contact STEVEN ARICK
Regulation Number870.4330
Classification Product Code
DRY  
Date Received03/27/1987
Decision Date 06/05/1987
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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