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

    TOP VENULA I.V. CATHETER SET

    K Number: K832624 · Decision Nov 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    12
    Review Days
    109

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    Basic Information

    Device Name
    TOP VENULA I.V. CATHETER SET
    K Number
    K832624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Top Surgical Manufacturers Co.
    Date Received
    August 4, 1983
    Decision Date
    November 21, 1983
    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 Top Surgical Manufacturers Co.

    K Number Device Name
    K844343 TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
    K843415 TOP HYPODERMIC SYRINGE LUER LOCK
    K843313 TOP DISPOSABLE SPINAL NEEDLE
    K843414 TOP HYPODERMIC SYRINGE PISTON
    K841119 TOPS DISPOS. INFUSION SET/HEMODIALYSIS
    K841025 TOP DISPOSABLE INFUSION SET
    K832625 TOP THREE WAY STOPCOCK
    K832626 TOP STERILE DISPOS. HYPODERMIC NEEDLES
    K832622 WINGED INFUSION SET
    K832621 TOP DISPOSABLE PLASTIC SYRINGES
    Search all 12 clearances from Top Surgical Manufacturers Co. →