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

    EXELINT ALUMINUM HUB BLUNT NEEDLES

    K Number: K101309 · Decision Oct 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    7
    Review Days
    163

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    Basic Information

    Device Name
    EXELINT ALUMINUM HUB BLUNT NEEDLES
    K Number
    K101309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exelint International, Co.
    Date Received
    May 10, 2010
    Decision Date
    October 20, 2010
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Exelint International, Co.

    K Number Device Name
    K251089 EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
    K152183 EXELINT SecureTouch Safety Hypodermic Needle
    K020189 EXEL BUTTERFLY SCALP VEIN SET
    K010197 EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
    K003627 EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
    K001496 A.V. FISTULA NEEDLE