BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Merit RadialFlo Arterial Catheter

    K Number: K182538 · Decision Jan 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    Merit RadialFlo Arterial Catheter
    K Number
    K182538
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Singapore Pte. , Ltd.
    Date Received
    September 14, 2018
    Decision Date
    January 16, 2019
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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