Device typeAortic open-surgery heart valve bioprosthesis: A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.
FDA categoryHeart-Valve, Non-Allograft Tissue
Device ID00690103195002
Catalog number11500A27
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Size27MM