FDA 510(k) Applications for Medical Device Product Code "OHA"
(Heart Valve, More Than Minimally Manipulated Allograft)

FDA 510(k) Number Applicant Device Name Decision Date
K092021 CRYOLIFE, INC. CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) 05/25/2010
K083106 CRYOLIFE, INC. CRYOVALVE SG PULMONARY VALVE AND CONDUIT 02/06/2009
K033484 CRYOLIFE, INC. HUMAN HEART VALVE, CRYOVALVE SG 02/07/2008


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