Device Dossier
Catheter balloon inflation system, single-use
Device Dossier for Catheter balloon inflation system, single-use (Catheter balloon inflation system, single-use, Class IIa, sponsor B Braun). ARTG…
- GMDN category: Catheter balloon inflation system, single-use
- Sponsor: B Braun
Intended purpose
A set of items ( part of a customised procedure kit for endovascular interventions in cadiology, radiology & hemodynamics)) used to manually inflate and regulate pressure within the balloon dilation catheter and to deflate the balloon during a medical procedure, such as in angioplasty and angiography procedures. The device is used outside the patient.