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

    PICC

    K Number: K042126 · Decision Aug 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    110
    Review Days
    21

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    Basic Information

    Device Name
    PICC
    K Number
    K042126
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Arrow Intl., Inc.
    Date Received
    August 6, 2004
    Decision Date
    August 27, 2004
    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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