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

    DRAGON HEART I.V. SET

    K Number: K043235 · Decision Mar 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    2
    Review Days
    106

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    Basic Information

    Device Name
    DRAGON HEART I.V. SET
    K Number
    K043235
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dragon Heart Medical Devices Co., Ltd.
    Date Received
    November 22, 2004
    Decision Date
    March 8, 2005
    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 Dragon Heart Medical Devices Co., Ltd.

    K Number Device Name
    K042547 DRAGON HEART PISTON SYRINGE