Device Dossier
NC Quantum Apex Monorail - Catheter, angioplasty, balloon dilatation
Device Dossier for NC Quantum Apex Monorail - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III, sponsor…
- GMDN category: Catheter, angioplasty, balloon dilatation
Intended purpose
The NC Quantum Apex Monorail PTCA Dilation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Functional description
The NC Quantum Apex Monorail has a low compliance balloon near the distal tip. The distal section is dual lumen and coaxial. The outer lumen is used for inflation of the balloon and the inner lumen permits the use of guidewires to facilitate advancement of the catheter to and through the stenosis or stent to be dilated. The proxmial section of the rapid exchange catheter is a single-lumen, sheathed stainless steel hypotube with a single luer port hub for inflation/deflation of the balloon.