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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 K021694
Device Name CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-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 Received05/22/2002
Decision Date 01/08/2003
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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