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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 K024058
Device Name MODIFICATION TO CARDEON AEGIS CATHETER
Applicant
CARDEON CORP.
10161 BUBB RD.
CUPERTINO,  CA  95014 -4133
Applicant Contact JANE BEGGS
Correspondent
CARDEON CORP.
10161 BUBB RD.
CUPERTINO,  CA  95014 -4133
Correspondent Contact JANE BEGGS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/09/2002
Decision Date 12/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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