Device Dossier
Aristotle Guidewires - Catheter guide wire
Device Dossier for Aristotle Guidewires - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Life Healthcare).…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
The Aristotle Guidewire Family is intended for use within the peripheral or neurovasculature to introduce and position catheters and other interventional devices. The guidewires are not intended for use in the coronary vasculature.
Functional description
The Aristotle guidewires and accessories are used to facilitate placement of devices in the peripheral and neurovasculature. The guidewires’ ability to be guided through the vasculature by a clinician to their desired location is enabled by the physical and material properties of the guidewires which acts as a thin, maneuverable, element over which a catheter or other device may be advanced and positioned.