Device Dossier

INNOWI - Cardiac/peripheral vascular guidewire, single-use

Device Dossier for INNOWI - Cardiac/peripheral vascular guidewire, single-use (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor…

Intended purpose

Intended to facilitate the introduction and placement of catheters or other interventional or diagnostic devices within the central circulatory system, the heart chambers and the coronary vasculature during diagnostic or interventional procedures.

Functional description

The devices are guidewires consisting of a core wire made of stainless steel. The distal tip of the guidewires is ground and inserted in a spring coil made of stainless steel. The entire length is covered with PTFE coating.

TGA Public Summary