Device Classification Name |
system, catheter control, steerable
|
510(k) Number |
K120834 |
Device Name |
CORPATH 200 SYSTEM |
Applicant |
CORINDUS INC. |
5523 RESEARCH PARK DRIVE |
SUITE 110 |
BALTIMORE,
MD
21228
|
|
Applicant Contact |
MONA ADVANI |
Correspondent |
CORINDUS INC. |
5523 RESEARCH PARK DRIVE |
SUITE 110 |
BALTIMORE,
MD
21228
|
|
Correspondent Contact |
MONA ADVANI |
Regulation Number | 870.1290
|
Classification Product Code |
|
Date Received | 03/19/2012 |
Decision Date | 07/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01076036 NCT01275092
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|