BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CorMatrix Tyke

    K Number: K152127 · Decision Feb 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    7
    Review Days
    188

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    Basic Information

    Device Name
    CorMatrix Tyke
    K Number
    K152127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cormatrix Cardiovascular, Inc.
    Date Received
    July 31, 2015
    Decision Date
    February 4, 2016
    Product Code
    DXZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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    Other Clearances by Cormatrix Cardiovascular, Inc.

    K Number Device Name
    K181038 CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
    K140306 CORMATRIX PROTECT ECM ENVELOPE
    K140789 CORMATRIX ECM FOR VASCULAR REPAIR
    K111187 PATCH, PLEDGET AND INTRACARDIAC
    K063349 CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
    K051405 REGENSIS PERICARDIAL PATCH