Device Dossier

PTCA Balloon Dilatation Catheter-DHC series - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for PTCA Balloon Dilatation Catheter-DHC series - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

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

The PTCA Balloon Dilatation Catheter is designed to allow rapid exchange of the catheter using aguidewire. The proxinal shaft is a PTFE coated stainless steel tube to allow pushability, trackabilityand crossability to ensure optinal balloon placement and expansion. Balloon material allows highpressure dilatation.Two radiopaque markers located in balloon to enable fluoroscopy.

TGA Public Summary