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510(k) K063644

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2007
Date Received
December 7, 2006
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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  • K081225 — CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (September 5, 2008)
  • K073304 — CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBL (December 20, 2007)

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  • K232970 — Hem-o-lok® Ligating Clips (January 12, 2024)
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