BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GRAFTGUARD PRESSURE CONTROLLING SYRINGE

    K Number: K082725 · Decision Dec 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    14
    Review Days
    91

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    Basic Information

    Device Name
    GRAFTGUARD PRESSURE CONTROLLING SYRINGE
    K Number
    K082725
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maquet Cardiovascular, LLC
    Date Received
    September 17, 2008
    Decision Date
    December 17, 2008
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

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