QOH · Class II · 21 CFR 870.4150

FDA Product Code QOH: Extracorporeal System For Carbon Dioxide Removal

An Extracorporeal System For Carbon Dioxide Removal Is A System Of Devices And Accessories That Provides Assisted Extracorporeal Carbon Dioxide Removal From The Patient's Blood In Patients With Acute Respiratory Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent. The Main Devices And Accessories Of The System Include, But Are Not Limited To, The Console (hardware), Software, And Disposables, Including, But Not Limited To, A Gas Exchanger, Blood Pump, Cannulae, Tubing, Filters, And Other Accessories (e.g., Monitors, Detectors, Sensors, Connectors).

Leading manufacturers include Alung Technologies, Inc..

1
Total
0
Cleared
254d
Avg days
2021
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Extracorporeal System For Carbon Dioxide Removal Devices (Product Code QOH)

1 devices
1–1 of 1
Not Cleared Nov 13, 2021
Hemolung Respiratory Assist System
DEN210006
Alung Technologies, Inc.
Cardiovascular · 254d

About Product Code QOH - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QOH since 2021, with 0 receiving FDA clearance (average review time: 254 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QOH devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →