Device Dossier
DuraSheath - Vascular introducer kit
Device Dossier for DuraSheath - Vascular introducer kit (Vascular catheter introduction set, nonimplantable, Class III, sponsor Diverse Devices). ARTG…
- GMDN category: Vascular catheter introduction set, nonimplantable
Intended purpose
The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the human vasculature, including but not limited to femoral access.
Functional description
Introducer sheath tubing connected at the proximal end to a haemostasis valve with side port tubing, connected to a plastic 3-way stopcock valve. Side port is used for flushing the introducer sheath. Sheath introduced into the vascular system with the aid of the dilator. Haemostasis valve at proximal end of introducer sheath conforms & seals around guide wires & catheters to reduce blood leakage. Radiopaque marker helps identify distal end. Hydrophobic silicone coating on distal 15cm portion.