Device Classification Name |
Clip, Implantable
|
510(k) Number |
K091017 |
Device Name |
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 |
Applicant |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
KIMBERLEE LEON |
Correspondent |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
KIMBERLEE LEON |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 04/09/2009 |
Decision Date | 04/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|