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

    VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS

    K Number: K052475 · Decision Sep 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    3
    Review Days
    370

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    Basic Information

    Device Name
    VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS
    K Number
    K052475
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vygon Us, LLC
    Date Received
    September 9, 2005
    Decision Date
    September 14, 2006
    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 Vygon Us, LLC

    K Number Device Name
    K033704 MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
    K040707 PACKAGING TRAY AND COMPONENTS