Pleural drainage system

A pleural drainage system is a sterile assembly of devices designed to remove air or fluid from the pleural cavity using suction. It typically includes a pleural catheter, a water-seal drainage unit with multiple chambers, and a suction regulator that connects to a hospital’s central vacuum system, and is used clinically to re-expand the lung after surgery or to manage conditions like pneumothorax and hemothorax.

This category refers exclusively to single-use devices that do not contain pharmaceuticals. As such, these systems are regulated as medical devices intended for one-time patient use and are supplied sterile for immediate clinical application, with regulatory requirements focused on their design, performance, and sterility as single-use products.