Device Dossier

Cardiopulmonary bypass system centrifugal pump

Device Dossier for Cardiopulmonary bypass system centrifugal pump (Cardiopulmonary bypass system centrifugal pump, Class IIa, sponsor Spectrum Medical).…

Intended purpose

A sterile device intended to be connected to a Quantum centrifugal drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion. It includes a spinning rotor and flow channels. It may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. This is a single-use device

TGA Public Summary