Device Classification Name |
system, catheter control, steerable
|
510(k) Number |
K152999 |
Device Name |
CorPath 200 System |
Applicant |
CORINDUS, INC. |
309 Waverley Oaks Road |
Suite 105 |
Waltham,
MA
02452
|
|
Applicant Contact |
Tal Wenderow |
Correspondent |
CardioMed Device Consultants |
5523 Research Park Drive, Suite 205 |
Baltimore,
MD
21228
|
|
Correspondent Contact |
Mona Advani |
Regulation Number | 870.1290
|
Classification Product Code |
|
Date Received | 10/13/2015 |
Decision Date | 03/18/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02371785
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|