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

    LIFEVALVE CENTRAL VENOUS CATHTER

    K Number: K031718 · Decision Jul 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    16
    Review Days
    29

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    Basic Information

    Device Name
    LIFEVALVE CENTRAL VENOUS CATHTER
    K Number
    K031718
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Horizon Medical Products, Inc.
    Date Received
    June 3, 2003
    Decision Date
    July 2, 2003
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Horizon Medical Products, Inc.

    K Number Device Name
    K033473 MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
    K032754 VORTEX MP
    K032557 TRIUMPH VTX WITH LIFEVALVE CATHETER
    K022905 LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
    K013871 LIFEGUARD SAFETY INFUSION SET
    K011916 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
    K010767 LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
    K010189 VORTEX ACCESS SYSTEM
    K994196 HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
    K951814 TRIUMPH-1 PORT
    Search all 16 clearances from Horizon Medical Products, Inc. →