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

    VYGON 2 FR EPICUTANEO PUR-CATHETER

    K Number: K993052 · Decision Aug 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    48
    Review Days
    325

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    Basic Information

    Device Name
    VYGON 2 FR EPICUTANEO PUR-CATHETER
    K Number
    K993052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vygon Corp.
    Date Received
    September 13, 1999
    Decision Date
    August 3, 2000
    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 Corp.

    K Number Device Name
    K121105 NUTRISAFE 2 FEEDING TUBE
    K100163 NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
    K073493 HEPATOSTAT SET
    K070705 MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
    K061796 HEPATOSTAT SET, MODEL 760X
    K061250 MULTICATH EXPERT
    K060944 NUTRISAFE 2
    K062425 LIFECATH S PICC AND MIDLINE CATHETER
    K052564 VYGON LEADER-FLEX
    K052881 VYGON LATEX FREE BIONECTOR
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