Device Classification Name |
System, Catheter Control, Steerable
|
510(k) Number |
K113628 |
Device Name |
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES |
Applicant |
CATHETER ROBOTICS INC |
500 INTERNATIONAL DRIVE |
MOUNT OLIVE,
NJ
07828
|
|
Applicant Contact |
JENNIFER ENGLUND |
Correspondent |
CATHETER ROBOTICS INC |
500 INTERNATIONAL DRIVE |
MOUNT OLIVE,
NJ
07828
|
|
Correspondent Contact |
JENNIFER ENGLUND |
Regulation Number | 870.1290
|
Classification Product Code |
|
Date Received | 12/08/2011 |
Decision Date | 06/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01139814
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|