Device typeSupersaturated oxygen therapy system catheter: A sterile, long and thin flexible tube inserted percutaneously into the vasculature and connected to a supersaturated oxygen (SSO2) therapy system for the infusion of autologous blood mixed with an SSO2 solution (producing oxygen-enriched hyperoxaemic blood) to a targeted coronary artery. It is typically an over-the-wire (OTW) catheter with a radiopaque marker band for fluoroscopic visualization. This is a single-use device.
FDA categorySystem, Oxygen, Aqueous
Device ID00862478000438
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Size5F