CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM


Device Classification Name

clip, implantable

510(k) Number K081225
Device Name CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
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 04/30/2008
Decision Date 09/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No