Device Dossier

Prelude Roadster Guide Sheath Introducer - Vascular introducer kit

Device Dossier for Prelude Roadster Guide Sheath Introducer - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III,…

Intended purpose

The Prelude Roadster Guide Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Functional description

The Prelude Roadster Guide Sheath is a manually operated mechanical device. It is manually guided into position percutaneously, and is then poised to receive vascular endoscopy devices designed to diagnose or treat vascular lesions. The device includes a hemostatic valve to reduce blood loss. The sheath is radiopaque and has a marker band near the tip to enable the position of the marker band to the tip to be visually verified under fluoroscopic imaging.

TGA Public Summary