Device Dossier

SureFlex Steerable Guiding Sheath - Catheter, intravascular, guiding

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

Intended purpose

For introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

Functional description

Following vascular access, the guidewire is introduced and advanced to the required depth. The dilator/sheath assembly is advanced over the guidewire to the transseptal puncture site. After confirmation of the transseptal puncture, the atrial septal defect is dilated using the dilator/sheath assembly. With the dilator removed, the sheath will act as a channel to give procedural devices access to the applicable chambers of the heart.

TGA Public Summary