Device Dossier

Catheter balloon inflation system, single-use

Device Dossier for Catheter balloon inflation system, single-use (Catheter balloon inflation system, single-use, Class IIa, sponsor Abbott Vascular…

Intended purpose

A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure - Single use device.

TGA Public Summary