Device Classification Name |
Clip, Implantable
|
510(k) Number |
K040832 |
Device Name |
C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 |
Applicant |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
SEVRINA CIUCCI |
Correspondent |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
SEVRINA CIUCCI |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 03/31/2004 |
Decision Date | 11/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|