Device Classification Name |
staple, implantable
|
510(k) Number |
K140118 |
Device Name |
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE |
Applicant |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
VEE ARYA |
Correspondent |
CARDICA, INC. |
900 SAGINAW DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
VEE ARYA |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 01/16/2014 |
Decision Date | 02/25/2014 |
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
|
|
|