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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J

    K Number: K024007 · Decision Jul 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    3
    Review Days
    222

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    Basic Information

    Device Name
    SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
    K Number
    K024007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunder Biomedical Tech. Co., Ltd.
    Date Received
    December 4, 2002
    Decision Date
    July 14, 2003
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Sunder Biomedical Tech. Co., Ltd.

    K Number Device Name
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