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

    TERUMO SURFLO I.V. CATHETER

    K Number: K133280 · Decision Jun 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    5
    Review Days
    230

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    Basic Information

    Device Name
    TERUMO SURFLO I.V. CATHETER
    K Number
    K133280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo (Philippines) Corporation
    Date Received
    October 25, 2013
    Decision Date
    June 12, 2014
    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 Terumo (Philippines) Corporation

    K Number Device Name
    K152362 Terumo SurGuard 3 Safety Hypodermic Needle
    K121607 TERUMO(R) NEEDLE
    K122249 TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
    K113422 TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE