510(k) DEN210006

Hemolung Respiratory Assist System by Alung Technologies, Inc. — Product Code QOH

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).