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

    MULTICATH EXPERT

    K Number: K061250 · Decision Sep 29, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    48
    Review Days
    148

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    Basic Information

    Device Name
    MULTICATH EXPERT
    K Number
    K061250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vygon Corp.
    Date Received
    May 4, 2006
    Decision Date
    September 29, 2006
    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 Vygon Corp.

    K Number Device Name
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    K073493 HEPATOSTAT SET
    K070705 MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
    K061796 HEPATOSTAT SET, MODEL 760X
    K060944 NUTRISAFE 2
    K062425 LIFECATH S PICC AND MIDLINE CATHETER
    K052564 VYGON LEADER-FLEX
    K052881 VYGON LATEX FREE BIONECTOR
    K051248 VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
    Search all 48 clearances from Vygon Corp. →