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 Abbott Vascular…
- GMDN category: Catheter balloon inflation system, single-use
Intended purpose
A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure - Single use device.