QOH

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Extracorporeal System For Carbon Dioxide Removal

Device class

Class II (moderate risk)

Regulation

21 CFR 870.4150

Medical specialty

Cardiovascular

FDA definition

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).

Adverse events (MAUDE)

2023: 50
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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