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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K983270
Device Name VOYAGER QUAD CANNULA
Applicant
Cardiothoracic Systems, Inc.
10600 N. Tantau Ave.
Cupertino,  CA  95014
Applicant Contact MIKE BILLIG
Correspondent
Cardiothoracic Systems, Inc.
10600 N. Tantau Ave.
Cupertino,  CA  95014
Correspondent Contact MIKE BILLIG
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/17/1998
Decision Date 07/28/1999
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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