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510(k) K070548

C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM by Cardica, Inc. — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2007
Date Received
February 26, 2007
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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  • K073304 — CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBL (December 20, 2007)

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