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510(k) Data Aggregation
K Number
DEN210006Device Name
Hemolung Respiratory Assist System
Manufacturer
Date Cleared
2021-11-13
(254 days)
Product Code
Regulation Number
870.4150Why did this record match?
Applicant Name (Manufacturer) :
ALung Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Hemolung Respiratory Assist System is indicated for respiratory support that provides extracorporeal carbon dioxide (CO2) removal from the patient's blood for up to 5 days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is expected.
Device Description
The Hemolung RAS provides low blood flow, veno-venous extracorporeal carbon dioxide removal (ECCO2R) using a single, 15.5 French dual lumen catheter inserted percutaneously in the femoral or jugular vein. The Hemolung RAS is not intended to provide therapeutic levels of oxygenation. During Hemolung therapy, blood passing through the circuit is oxygenated via room air sweep gas; however, at ultra-low extracorporeal blood flows, the limited oxygen carrying capacity of blood precludes meaningful oxygenation of mixed venous blood. The Hemolung RAS consists of three main components: C. Hemolung Controller, A. Hemolung Cartridge, and B. Hemolung Catheter.
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