Device Dossier

Firefighter NC PTCA balloon catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Firefighter NC PTCA balloon catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

The Firefighter NC PTCA balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and for balloon dilatation of a stent after implantation.

Functional description

The device is a non-compliant percutaneous transluminal coronary angioplasty (PTCA) rapid exchange system that consists of an integrated shaft and a balloon at the distal end of the catheter. The proximal end of the catheter has a standard luer to inflate or deflate the balloon by contrast medium. The coaxial dual lumen distal shaft creates the rapid exchange capability. The balloon catheter is coated with hydrophilic coating.

TGA Public Summary