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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K063349
Device Name CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
Applicant
Cormatrix Cardiovascular, Inc.
155 Moffett Park Dr.,
Suite A-101
Sunnyvale,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
Cormatrix Cardiovascular, Inc.
155 Moffett Park Dr.,
Suite A-101
Sunnyvale,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received11/06/2006
Decision Date 02/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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