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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K010117
Device Name GUIDANT AXIUS CORONARY SHUNT
Applicant
CARDIOTHORACIC SYSTEMS, INC.
10600 NORTH TANTAU AVE.
CUPERTINO,  CA  95014
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
CARDIOTHORACIC SYSTEMS, INC.
10600 NORTH TANTAU AVE.
CUPERTINO,  CA  95014
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number870.4450
Classification Product Code
DXC  
Date Received01/16/2001
Decision Date 04/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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