FDA 510(k), K063349, CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR

510(K) Number: K063349
Device Name: CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Device Classification Name: patch, pledget and intracardiac, petp, ptfe, polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 11/06/2006
Decision Date: 02/16/2007
Regulation Medical Specialty: Cardiovascular

Total pages: 255
Fully redacted pages: 98
Content pages: 157