510(k) Premarket Notification

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New Search Back To Search Results 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 Contact steven arick Regulation Number 870.4330 Classification Product Code DRY   Date Received 03/27/1987 Decision Date 06/05/1987 Decision substantially equivalent (SE) Classification Advisory Committee Cardiovascular Review Advisory Committee Cardiovascular Statement/Summary/Purged Status Purged, no summary or statement Type Traditional Reviewed by Third Party No Expedited Review