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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K063644
Device Name CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
Applicant
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Applicant Contact TIFFINI LALUDE
Correspondent
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Correspondent Contact TIFFINI LALUDE
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/07/2006
Decision Date 01/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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