Device Classification Name |
extracorporeal system for carbon dioxide removal
|
De Novo Number |
DEN210006 |
Device Name |
Hemolung Respiratory Assist System |
Requester |
ALung Technologies, Inc. |
2500 jane street, suite 1 |
pittsburgh,
PA
15203
|
|
Contact |
joe argyros |
|
Regulation Number | 870.4150
|
Classification Product Code |
|
Date Received | 03/04/2021 |
Decision Date | 11/13/2021 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|