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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 K152127
Device Name CorMatrix Tyke
Applicant
Cormatrix Cardiovascular, Inc.
1100 Old Ellis Rd.
Roswell,  GA  30076
Applicant Contact ANDREW M. GREEN
Correspondent
Cormatrix Cardiovascular, Inc.
1100 Old Ellis Rd.
Roswell,  GA  30076
Correspondent Contact ANDREW M. GREEN
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/31/2015
Decision Date 02/04/2016
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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