Device Dossier

Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation, coronary, basic, Class III,…

Intended purpose

The PTCA Balloon Dilatation Catheter is intended for dilatation of the stenotic portion (non-CTO) of coronary arteries for the purpose of improving myocardial perfusion.

Functional description

PTCA Semi-Compliant Balloon Dilatation Catheter is a rapid exchange of the catheter using a guidewire. The proximal shaft is a PTFE coated stainless steel tube which allows for proximal pushability with a smooth transition to the distal shaft which has a lubricious coating. Balloon allows for high pressure dilatation. Two radiopaque platinum markers are located within the balloon.

TGA Public Summary