Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K131772 |
Device Name |
CANTATA(R) 2.9 MICROCATHETER |
Applicant |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47402 -0489
|
|
Applicant Contact |
JENNIFER A RICHARDSON |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47402 -0489
|
|
Correspondent Contact |
JENNIFER A RICHARDSON |
Regulation Number | 870.1210
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/17/2013 |
Decision Date | 02/20/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|