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

    CORMATRIX PROTECT ECM ENVELOPE

    K Number: K140306 · Decision Aug 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    7
    Review Days
    189

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    Basic Information

    Device Name
    CORMATRIX PROTECT ECM ENVELOPE
    K Number
    K140306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cormatrix Cardiovascular, Inc.
    Date Received
    February 7, 2014
    Decision Date
    August 15, 2014
    Product Code
    FTM
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FTM Mesh, Surgical

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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)
    K152127 CorMatrix Tyke
    K140789 CORMATRIX ECM FOR VASCULAR REPAIR
    K111187 PATCH, PLEDGET AND INTRACARDIAC
    K063349 CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
    K051405 REGENSIS PERICARDIAL PATCH