Device Classification Name |
catheter remote control system
|
De Novo Number |
DEN140009 |
Device Name |
AMIGO REMOTE CATHETER SYSTEM |
Requester |
catheter robotics inc |
500 international drive suite 255 |
mount olive,
NJ
07828
|
|
Contact |
jennifer englund |
|
Regulation Number | 870.5700
|
Classification Product Code |
|
Date Received | 02/18/2014 |
Decision Date | 12/18/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|