Product Code: QOH FDA class 2 21 CFR 870.4150

Extracorporeal System For Carbon Dioxide Removal

Cardiovascular

The Extracorporeal System for Carbon Dioxide Removal is a cardiovascular device system providing assisted extracorporeal removal of carbon dioxide from a patient's blood in patients with acute respiratory failure where other treatments have failed and continued clinical deterioration is expected or the risk of death is imminent. The system includes a console, software, and disposables such as a gas exchanger, blood pump, cannulae, tubing, filters, and other accessories. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.4150 in the Cardiovascular specialty. It carries product code QOH and is not an implant and not life-sustaining.

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Basic Information

Product Code: QOH
Device Class: FDA class 2
Regulation Number: 870.4150
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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).