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

    EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET

    K Number: K003627 · Decision Feb 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    7
    Review Days
    76

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    Basic Information

    Device Name
    EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
    K Number
    K003627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Exelint International, Co.
    Date Received
    November 24, 2000
    Decision Date
    February 8, 2001
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Exelint International, Co.

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    K101309 EXELINT ALUMINUM HUB BLUNT NEEDLES
    K020189 EXEL BUTTERFLY SCALP VEIN SET
    K010197 EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
    K001496 A.V. FISTULA NEEDLE