Device Dossier

Cristal Balloon - Catheter, valvuloplasty, balloon dilatation

Device Dossier for Cristal Balloon - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty, balloon dilatation, Class III, sponsor Balt).…

Intended purpose

The Balt CRISTAL BALLOON catheters are designed and intended for paediatric and adult valvuloplasty.

Functional description

The CRISTAL BALLOON range of valvuloplasty dilatation catheters, are double lumen, over-the ?wire catheters with a balloon near the distal tip. The outer lumen is used for inflation and deflation of the balloon, and the inner lumen permits the use of guide wires to facilitate the advancement of the catheter to and through the stenosis in order to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at a recommended pressure.

TGA Public Summary