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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K031903
Device Name RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
Applicant
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL,  MN  55112 -5798
Applicant Contact STEPHANIE I ROBINSON
Correspondent
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL,  MN  55112 -5798
Correspondent Contact STEPHANIE I ROBINSON
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received06/20/2003
Decision Date 03/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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