Device Classification Name |
urethral insert with pump for bladder drainage
|
De Novo Number |
DEN130044 |
Device Name |
INFLOW INTRAURETHRAL VALVE-PUMP |
Requester |
vesiflo, inc. |
8672 154th ave ne |
redmond,
WA
98052
|
|
Contact |
kevin m connolly |
|
Regulation Number | 876.5140
|
Classification Product Code |
|
Date Received | 10/25/2013 |
Decision Date | 10/14/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|