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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 K111187
Device Name PATCH, PLEDGET AND INTRACARDIAC
Applicant
Cormatrix Cardiovascular, Inc.
155 Moffett Park Dr.
Suite 210
Sunnyvale,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
Cormatrix Cardiovascular, Inc.
155 Moffett Park Dr.
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received04/27/2011
Decision Date 07/26/2011
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
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