Device Dossier

Catheter, intravascular, guiding

Device Dossier for Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class IIa, sponsor AA-Med). ARTG record, intended purpose, GMDN…

Intended purpose

The catheter is intended to enable peripheral PTA interventions by - Facilitating, guiding and supporting a guidewire in order that the guidewire be able to cross the lesion, - allowing for guidewire exchanges to use the most adequate guidewire according to the challenging lesion, and/or - providing a conduit for the delivery of saline solutions and/or diagnostic contrast agents, allowing the vision of the state of the artery downstream of the lesion.

TGA Public Summary