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

    HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM

    K Number: K994196 · Decision Feb 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    16
    Review Days
    59

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    Basic Information

    Device Name
    HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
    K Number
    K994196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Horizon Medical Products, Inc.
    Date Received
    December 13, 1999
    Decision Date
    February 10, 2000
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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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
    K031718 LIFEVALVE CENTRAL VENOUS CATHTER
    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
    K951814 TRIUMPH-1 PORT
    Search all 16 clearances from Horizon Medical Products, Inc. →