Device Dossier

MEGA Ballast Access Platform - Catheter, intravascular, guiding

Device Dossier for MEGA Ballast Access Platform - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Balt). ARTG…

Intended purpose

Intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Functional description

The MEGA Ballast Access Platform consists of the MEGA Ballast Access Sheath, Dilator, Introducer Sheath, Rotating Hemostasis Valve (RHV), and Hemostasis Valve Adapter (HVA). The Dilator facilitates the percutaneous entry of the MEGA Ballast Access Sheath by forming an atraumatic transition of the MEGA Ballast Access Sheath through the skin and subcutaneous tissue to the vessel while protecting the integrity of the distal diameter of the MEGA Ballast Access Sheath.

TGA Public Summary