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…
- GMDN category: Angioplasty catheter, balloon dilatation, coronary, basic
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.