Device Classification Name |
clip, implantable
|
510(k) Number |
K070548 |
Device Name |
C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM |
Applicant |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
TIFFINI LALUDE |
Correspondent |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
TIFFINI LALUDE |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 02/26/2007 |
Decision Date | 03/29/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|