Device Dossier

Base Camp Sheath System 2.0 - Catheter, intravascular, guiding

Device Dossier for Base Camp Sheath System 2.0 - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Emergo). ARTG…

Intended purpose

The Route 92 Medical Sheath System 2.0 is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Functional description

Sheath, Dilator, Select Catheter and rotating hemostasis valve. Sheath: single-lumen, variable stiffness, radiopaque marker on distal end. Compatible with 8F or smaller catheters. Dilator placed in Sheath facilitates introduction of Sheath into femoral artery. The Dilator has radiopaque marker at distal tip. Select Catheter: single lumen, variable stiffness, radiopaque marker at distal tip; compatible with Sheath; shaped distal end to facilitate placement. Catheters have hydrophilic coating.

TGA Public Summary