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…
- GMDN category: Catheter, intravascular, guiding
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.