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

    VacLok AT Vacuum Syringe

    K Number: K163597 · Decision Jul 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    178
    Review Days
    218

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    Basic Information

    Device Name
    VacLok AT Vacuum Syringe
    K Number
    K163597
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    December 21, 2016
    Decision Date
    July 27, 2017
    Product Code
    PUR
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PUR Vacuum Syringe

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