Device Dossier

Opus Ventricular Catheter - Catheter, neurological, ventricular

Device Dossier for Opus Ventricular Catheter - Catheter, neurological, ventricular (Catheter, neurological, ventricular, Class III, sponsor Medtronic).…

Intended purpose

A flexible tube that is surgically inserted through the skull and brain to access the cerebrospinal fluid-filled cavities of the brain (ventricles). This device is single-use.

Functional description

The Opus Catheter is a ventricular catheter fabricated from silicone elastomer tubing, impregnated with barium sulfate to provide radiopacity. A right angle clip is packaged to angulate the catheter at the burr-hole without kinking. Each Opus Ventricular Catheter is packaged with an Opus Stylet designed to facilitate introduction of the catheter. The opus stylet has a hollow shaft, permitting a free flow of CSF during catheter placement.

TGA Public Summary