Device Dossier

NHancer Pro X Guide Wire Support Catheter - Catheter, intravascular, guiding

Device Dossier for NHancer Pro X Guide Wire Support Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor KD…

Intended purpose

NHancer Pro X Guide Wire Support Catheter is intended to support a guide wire during access of coronary and/or peripheral vasculature, allow the exchange of guide wires and provide a conduit for the delivery of diagnostic agents.

Functional description

NHancer ProX is a 0.014” OTW guide wire support catheter with a distal port to access the guide wire lumen (from proximal end until distal tip). The catheter has a radiopaque tip section to indicate distal end. The distal part has a deformable atraumatic tip to protect the vessel wall from puncture and center the wire in the vessel. Optional torquer can be used to lock the proximal part of the catheter to the wire so the guide wire and NHancer act as one integral device.

TGA Public Summary