510(k) K101866

CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH by Cryolife, Inc. — Product Code DXZ

K101866 is an FDA 510(k) premarket notification submitted by Cryolife, Inc. for the device "CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH". The FDA issued a decision of Substantially Equivalent on July 23, 2010. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Cryolife, Inc. has at least 10 other 510(k) clearances on record.