Device typeAortic bi-leaflet mechanical heart valve prosthesis: An artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about pyrolytic carbon or metal struts attached to the valve housing by hinges; the hinge points intersect the valve lumen resulting in a total of three openings. When pressurized blood hits the valve, the two halves of the circle fold away from the valve ring and allow blood to flow into the three openings before the valve flaps close again.
FDA categoryHEART-VALVE, MECHANICAL
Device ID05415067044297
Catalog number21AGN-751
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Outer Diameter21.0000 Millimeter