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

    MOBICATH TRANSSEPTAL NEEDLE

    K Number: K122832 · Decision Dec 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    10
    Review Days
    93

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    Basic Information

    Device Name
    MOBICATH TRANSSEPTAL NEEDLE
    K Number
    K122832
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Great Batch Medical
    Date Received
    September 17, 2012
    Decision Date
    December 19, 2012
    Product Code
    DRC
    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
    DRC Trocar

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