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

    6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC

    K Number: K043502 · Decision Jan 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    297
    Applicant Total
    566
    Review Days
    25

    Basic Information

    Device Name
    6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
    K Number
    K043502
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. BARD, INC.
    Date Received
    December 20, 2004
    Decision Date
    January 14, 2005
    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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