CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES


Device Classification Name

clip, implantable

510(k) Number K073304
Device Name CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
Applicant
CARDICA, INC.
900 saginaw dr.
redwood city, 
CA 
94063

Applicant Contact iskra mrakovic
Correspondent
CARDICA, INC.
900 saginaw dr.
redwood city, 
CA 
94063

Correspodent Contact iskra mrakovic
Regulation Number 878.4300
Classification Product Code
FZP  
Date Received 11/23/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No