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

    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)

    K Number: K181038 · Decision Oct 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    174

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    Basic Information

    Device Name
    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)
    K Number
    K181038
    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
    April 19, 2018
    Decision Date
    October 10, 2018
    Product Code
    PSQ
    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
    PSQ Intracardiac Patch Or Pledget, Biologically Derived

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    Other Clearances by Cormatrix Cardiovascular, Inc.

    K Number Device Name
    K152127 CorMatrix Tyke
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    K140789 CORMATRIX ECM FOR VASCULAR REPAIR
    K111187 PATCH, PLEDGET AND INTRACARDIAC
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