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,…
- GMDN category: Vascular catheter introduction set, nonimplantable
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.