Device Dossier
Masters Series Aortic Mechanical Heart Valve Poly HP Sewing Cuff Model 15AHPJ-505 - Aortic bi-leaflet mechanical heart valve prosthesis
Device Dossier for Masters Series Aortic Mechanical Heart Valve Poly HP Sewing Cuff Model 15AHPJ-505 - Aortic bi-leaflet mechanical heart valve…
- GMDN category: Aortic bi-leaflet mechanical heart valve prosthesis
Intended purpose
The Masters Series Aortic Mechanical Heart Valve Poly HP Sewing Cuff Model 15AHPJ-505 is intended to replace native aortic heart valves or previously implanted prosthetic valves. The valve is indicated for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic heart valve or as a replacement for an aortic prosthetic heart valve. The target patient population for these valves is pediatric patients with a diseased, damaged, or malfunctioning aortic valve.
Functional description
The valves are rotatable, bi-leaflet replacement heart valves manufactured from pyrolytic carbon designed for implantation in the aortic position. The valve is designed for supra-annular cuff placement and includes a metallic ring assembly within the sewing cuff that allows the valve to be rotated in-situ.