Device Dossier
Toray Inoue Balloon Kit - Catheter, valvuloplasty, balloon dilatation
Device Dossier for Toray Inoue Balloon Kit - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty, balloon dilatation, Class III, sponsor…
- GMDN category: Catheter, valvuloplasty, balloon dilatation
Intended purpose
The Toray Inoue Balloon Kit is indicated for Percutaneous Transvenous Mitral Commissurotomy (PTMC) in patients with mirtal stenosis.
Functional description
the kit contains a Inoue baloon catheter for dilation of mitral valve, Balloon Stretching tube for elongation of the balloon, Dilator for the dilation of the insetion site, Guidewire for guiding of the cathter and dilator, Stylet for directing the balloon to the valve, Syringe for inflation of the balloon, and ruler for the maesurement of the balloon diameter.