510(k) K063349

CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR by Cormatrix Cardiovascular, Inc. — Product Code DXZ

K063349 is an FDA 510(k) premarket notification submitted by Cormatrix Cardiovascular, Inc. for the device "CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR". The FDA issued a decision of Substantially Equivalent on February 16, 2007. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Cormatrix Cardiovascular, Inc. has at least 6 other 510(k) clearances on record.