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

    KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD

    K Number: K001424 · Decision Jul 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    6
    Review Days
    77

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    Basic Information

    Device Name
    KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
    K Number
    K001424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kawasumi Laboratories America, Inc.
    Date Received
    May 5, 2000
    Decision Date
    July 21, 2000
    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 Kawasumi Laboratories America, Inc.

    K Number Device Name
    K102890 K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
    K030385 IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR
    K001423 KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
    K001426 KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
    K001043 KAWASUMI LABORATORY BLOOD DRAWING KIT