Device Dossier

Peripheral vascular guidewire

Device Dossier for Peripheral vascular guidewire (Peripheral vascular guidewire, Class IIa, sponsor Abbott Vascular Division of Abbott Medical). ARTG…

Intended purpose

The ViperWire atherectomy guide wire is intended for use with CSI (Cardiovascular Systems, Inc) Orbital Atherectomy Devices (OAD). The ViperWire Advance Peripheral Guide Wires are smooth, stainless steel wires, with a silicone coating, and a radiopaque distal spring tip. The Guide wire allow for proper positioning of the OAD crown within peripheral arteries and provides a centre of rotation for the OAD shaft. The Guide Wire Torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire.

TGA Public Summary