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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K032068
Device Name CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
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 Number870.4240
Classification Product Code
DTR  
Subsequent Product Codes
DTP   DTZ   KFM  
Date Received07/03/2003
Decision Date 08/22/2003
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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