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

    5 FR Dual Lumen Piper PICC

    K Number: K181904 · Decision Sep 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    3
    Review Days
    71

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    Basic Information

    Device Name
    5 FR Dual Lumen Piper PICC
    K Number
    K181904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Piper Access, LLC
    Date Received
    July 16, 2018
    Decision Date
    September 25, 2018
    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 Piper Access, LLC

    K Number Device Name
    K210047 Stiletto Extended Dwell Catheter
    K191976 Piper GO-IO Intraosseous Infusion System