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

    Cathtong I PICC Catheter

    K Number: K153469 · Decision Sep 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    6
    Review Days
    275

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    Basic Information

    Device Name
    Cathtong I PICC Catheter
    K Number
    K153469
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    L&Z Us, Inc.
    Date Received
    December 1, 2015
    Decision Date
    September 1, 2016
    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 L&Z Us, Inc.

    K Number Device Name
    K233149 CATHTONG III Tapered PICC Catheter
    K232571 CATHTONG™ II PICC Catheter
    K232594 CATHTONG™ II PICC Catheter
    K172039 CATHTONG II PICC Catheter
    K170486 CATHTONG II PICC Catheter