Device Dossier

Drivewire 24 Guidewire - Cardiac/peripheral vascular guidewire, single-use

Device Dossier for Drivewire 24 Guidewire - Cardiac/peripheral vascular guidewire, single-use (Cardiac/peripheral vascular guidewire, single-use, Class…

Intended purpose

The Drivewire 24 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.

Functional description

The Drivewire 24 is a 0.024” diameter steerable guidewire with a deflectable tip controlled via a proximal handle to aid in accessing vasculature. The distal section is radiopaque to aid fluoroscopic imaging and has a hydrophilic polymer coating. The guidewire packaging includes a torque device to aid the use of the guidewire and is not intended to enter the patient’s body.

TGA Public Summary