Device Dossier

CPS Direct Universal Slittable Outer Guide Catheter - Catheter, intravascular, guiding

Device Dossier for CPS Direct Universal Slittable Outer Guide Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III,…

Intended purpose

To provide a transvenous conduit for navigation of coronary venous system anatomy and delivery pathway during cardiac surgery procedures for contrast media, implantable left heart pacing leads, or other delivery tools.

Functional description

The catheter is designed to facilitate left heart lead delivery during cardiac resynchronization therapy (CRT) procedures. The catheter provides access to the coronary venous system and acts as a conduit for contrast medium, implantable coronary leads, or other devices. The package includes 1 outer guide catheter, 1 dilator and 2 valve bypass tools.

TGA Public Summary