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

    DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK

    K Number: K930974 · Decision Nov 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    6
    Review Days
    252

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    Basic Information

    Device Name
    DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK
    K Number
    K930974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intl. Medical Consultants
    Date Received
    February 24, 1993
    Decision Date
    November 3, 1993
    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 Intl. Medical Consultants

    K Number Device Name
    K931119 DURHAM; NON CORING WINGED ADMINISTRATION SET
    K930927 DURHAM;T ADAPTOR EXTENSIONSET W/INJECTION SITE
    K930926 DURHAM; Y CHECK SET-LUER LOCK W/INJECTION SITE
    K930751 DURHAM; EXTENSION TUBE LUER LOCK W/INJECTION SITE
    K930750 DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER