Device Dossier

NHancer Rx Dual Lumen Rapid Exchange Catheter - Catheter, intravascular, guiding

Device Dossier for NHancer Rx Dual Lumen Rapid Exchange Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor…

Intended purpose

The NHancer Rx Dual Lumen Rapid Exchange catheter is intended to support and facilitate the rapid exchange of guidewires during access of coronary and/or peripheral vasculature and to provide a conduit for the delivery of diagnostic agents.

Functional description

The NHancer Rx is a dual lumen catheter intended to be used in the coronary and/or peripheral vasculature for patients suffering from coronary/peripheral artery disease. NHancer Rx is a 0.014” Rapid Exchange guide wire support catheter. It has an over-the-wire and a rapid exchange delivery lumens. It has a length of 135cm; 2 depth markings; 2 radiopaque markers; hydrophilic coating on the distal end; MDX (silicone) coating on the lumen.

TGA Public Summary