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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K030141
Device Name MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
Applicant
CARDIOVENTION, INC.
3045 STENDER WAY
SANTA CLARA,  CA  95054
Applicant Contact TESSA YAMUT
Correspondent
CARDIOVENTION, INC.
3045 STENDER WAY
SANTA CLARA,  CA  95054
Correspondent Contact TESSA YAMUT
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received01/15/2003
Decision Date 02/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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