510(k) DEN210006
DEN210006 is an FDA 510(k) premarket notification submitted by Alung Technologies, Inc. for the device "Hemolung Respiratory Assist System". The FDA issued a decision of De Novo Granted on November 13, 2021. The device falls under product code QOH (Extracorporeal System For Carbon Dioxide Removal), a Class II device regulated under 21 CFR 870.4150.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 13, 2021
- Date Received
- March 4, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extracorporeal System For Carbon Dioxide Removal
- Device Class
- Class II
- Regulation Number
- 870.4150
- Review Panel
- CV
- Submission Type
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).