Device Category Dossier

Aortic bi-leaflet mechanical heart valve prosthesis

Device Category Dossier for Aortic bi-leaflet mechanical heart valve prosthesis. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Device: Masters Series Aortic Mechanical Heart Valve Poly HP Sewing Cuff Model 15AHPJ-505 - Aortic bi-leaflet mechanical heart valve prosthesis
Device: Regent™ Mechanical Heart Valve with FlexCuff™ - Aortic bi-leaflet mechanical heart valve prosthesis
Device: Masters Series Aortic Mechanical Heart Valves with Expanded Polyster Sewing Cuff - Aortic bi-leaflet mechanical heart valve prosthesis
Device: Masters Series Aortic Mechanical Heart Valves with Hemodynamic Plus (HP) Sewing Cuff - Aortic bi-leaflet mechanical heart valve prosthesis
Device: Medtronic Open Pivot heart valve, Model 505DA - Prosthesis, internal, valve, cardiac, artificial
Device: Medtronic Open Pivot heart valve, Model 500FA
Device: Regent Mechanical Heart Valve - Aortic bi-leaflet mechanical heart valve prosthesis

Mechanical aortic heart valves are prosthetic devices intended to replace native aortic heart valves or previously implanted prosthetic valves. These valves are indicated for use in patients with diseased, damaged, or malfunctioning aortic heart valves, including paediatric populations.