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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 K090872
Device Name MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
Applicant
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Applicant Contact KIMBERLEE LEON
Correspondent
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Correspondent Contact KIMBERLEE LEON
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/30/2009
Decision Date 04/21/2009
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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