Device Dossier
Wedge Microcatheter - Intravascular microflow catheter
Device Dossier for Wedge Microcatheter - Intravascular microflow catheter (Intravascular microflow catheter, Class III, sponsor Life Healthcare). ARTG…
- GMDN category: Intravascular microflow catheter
Intended purpose
The Wedge Microcatheter is intended for general intravascular use, including the peripheral and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents.
Functional description
A single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semirigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Radiopaque markers at the distal end facilitate fluoroscopic visualisation. A large diameter distal segment helps provide stability for navigation. The outer surface is coated with a hydrophilic polymer to increase lubricity. A luer fitting allows attachment of accessories