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510(k) K101018

CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 by Cardica, Inc. — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2010
Date Received
April 13, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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  • K073123 — CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 (December 6, 2007)

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