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).…
- GMDN category: Catheter, valvuloplasty, balloon dilatation
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.