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

    HANCOCK PERICARDIAL PATCH

    K Number: K830863 · Decision Aug 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    69
    Review Days
    166

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    Basic Information

    Device Name
    HANCOCK PERICARDIAL PATCH
    K Number
    K830863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    March 18, 1983
    Decision Date
    August 31, 1983
    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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