Device typeCadaveric open-surgery heart valve bioprosthesis, decellularized: An implantable allograft heart valve obtained from a human cadaver intended to be implanted during open heart surgery to repair or replace a dysfunctional natural heart valve. It is processed to render the tissue decellularized; 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, More Than Minimally Manipulated Allograft
Device ID00877234000454
Catalog numberSGPV10
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information
SizeInternal Diameter: Ranges from 6mm to 36mm (allograft specific)