Device Dossier

FARADRIVE Steerable Sheath - Catheter, intravascular, guiding

Device Dossier for FARADRIVE Steerable Sheath - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston…

Intended purpose

The FARADRIVE Steerable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum

Functional description

The FARADRIVE Sheath is intended to facilitate the placement of diagnostic and/or therapeutic intracardiac devices into the vasculature and into chambers of the heart during percutaneous catheter ablation procedures. The sheath deflection facilitates catheter positioning. The Steerable Sheath has a 13 French inner diameter with single plane deflection and active straightening which allows the shaft to return to a zero-degree deflection position.

TGA Public Summary