Device Dossier

Catheterization kit, cardiac

Device Dossier for Catheterization kit, cardiac (Vascular catheter introduction set, nonimplantable, Class IIa, sponsor Demax Medical). ARTG record,…

Intended purpose

The Peelable Introducers is used for percutaneous introduction of pacemaker leads into the venous vasculature. The introducer needle is used to apply channel for guidewire; The guidewire is mainly used to provide convenience for the insertion of dilator and sheath; The dilator is used to dilate the vessel to facilitate for inserting the sheath into the vessel; The sheath is used to apply channel for insertion of pacemaker lead; Straightener is used to make the guidewire straightened.

TGA Public Summary