FDA.reportPublic FDA data

De Novo DEN210006

Device
Hemolung Respiratory Assist System
Contact
joe argyros
De Novo number
DEN210006
Product code
QOH
Regulation
870.4150
Classification name
extracorporeal system for carbon dioxide removal
Decision
granted (DENG)
Decision date
2021-11-13
Date received
2021-03-04
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Direct

Current FDA Classification#

Product code
QOH
Device name
Extracorporeal System For Carbon Dioxide Removal
Medical specialty
Cardiovascular
Device class
2
Regulation
870.4150
Implant
N
Life sustain/support
N