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

    NITROGLYCERIN INFUSION SET

    K Number: K853019 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    8
    Review Days
    118

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    Basic Information

    Device Name
    NITROGLYCERIN INFUSION SET
    K Number
    K853019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Lyphomed, Inc.
    Date Received
    July 17, 1985
    Decision Date
    November 12, 1985
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Lyphomed, Inc.

    K Number Device Name
    K910142 SPARK KIT(R), MODIFICATION
    K864509 SPARK-KIT(TM)
    K853086 SECONDARY ADMINISTRATION SET
    K852881 VENTED SECONDARY IV ADMINISTRATION SET
    K852882 MAXIFILL TRANSFER SET
    K842678 I.V. TRANSFER SPIKE
    K842345 MAXIFILL TRANSFER SET