Device Dossier

PTFE Coated Angiographic Guide Wire - Catheter guide wire

Device Dossier for PTFE Coated Angiographic Guide Wire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor…

Intended purpose

Steerable Guide Wires that are used for the introduction and placement of interventional devices in the coronay and peripheral vasculature, and may be used to reach and cross target leisions or facilitate the subsitution of of one diagnostic or interventional device for another.

Functional description

The guide wires are construted of an inner core wire, a safety wire and an outer spring coil. the ends of the wire are welded and polished for strenth and smoothnees, creating an atraumatic finish. The wires are PTFE coated to allow the wire to move smoothly thourgh the catheter.

TGA Public Summary