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

    SPARK KIT(R), MODIFICATION

    K Number: K910142 · Decision May 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    8
    Review Days
    120

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    Basic Information

    Device Name
    SPARK KIT(R), MODIFICATION
    K Number
    K910142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Lyphomed, Inc.
    Date Received
    January 14, 1991
    Decision Date
    May 14, 1991
    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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    K864509 SPARK-KIT(TM)
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    K852881 VENTED SECONDARY IV ADMINISTRATION SET
    K852882 MAXIFILL TRANSFER SET
    K842678 I.V. TRANSFER SPIKE
    K842345 MAXIFILL TRANSFER SET