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 collection of sterile devices used with a balloon dilatation catheter to manually inflate and regulate pressure within the catheter's balloon (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon in association with a medical procedure. These are single use devices.

TGA Public Summary