Device Category Dossier

Electrocautery system, line-powered

Device Category Dossier for Electrocautery system, line-powered. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Vascular access systems comprise a single-use sterile flexible catheter with a heating element on the distal tip that tracks over a guidewire to approximate vessel walls, which are then thermally coagulated, sealed and cut to create an anastomosis. These systems establish a connection between an artery and a vein to create an arteriovenous fistula , typically in patients with minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site.