Device Dossier

Euphora Rapid Exchange Balloon Dilation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Euphora Rapid Exchange Balloon Dilation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter,…

Intended purpose

The balloon catheter expands the stenotic portion of a coronary artery or bypass graft stenosis during PTCA. Balloon catheter models that at 2.00 to 4.00 mm in diameter are also indicated for post-delivery expansion of balloon-expandable stents.

Functional description

The Euphora Rapid Exchange Balloon Dilation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. It contains one balloon dilatation catheter, one flushing cannula, one refold tool, one looper device and one compliance chart.

TGA Public Summary