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

    EXEL BUTTERFLY SCALP VEIN SET

    K Number: K020189 · Decision Mar 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    433

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    Basic Information

    Device Name
    EXEL BUTTERFLY SCALP VEIN SET
    K Number
    K020189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Exelint International, Co.
    Date Received
    January 18, 2002
    Decision Date
    March 27, 2003
    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 Exelint International, Co.

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    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
    K101309 EXELINT ALUMINUM HUB BLUNT NEEDLES
    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