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

    Liebel-Flarsheim IBP Transfer Set

    K Number: K193010 · Decision Nov 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    386

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    Basic Information

    Device Name
    Liebel-Flarsheim IBP Transfer Set
    K Number
    K193010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Liebel-Flarsheim Company, LLC
    Date Received
    October 29, 2019
    Decision Date
    November 18, 2020
    Product Code
    PQH
    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
    PQH Iodinated Contrast Media Transfer Tubing Set

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    Other Clearances by Liebel-Flarsheim Company, LLC

    K Number Device Name
    K152361 OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System