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

    PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV

    K Number: K850888 · Decision May 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    7
    Review Days
    64

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    Basic Information

    Device Name
    PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV
    K Number
    K850888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Creative Care Systems, Inc.
    Date Received
    March 4, 1985
    Decision Date
    May 7, 1985
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Creative Care Systems, Inc.

    K Number Device Name
    K861406 NON-KOR WINGED INFUSION SETS
    K852831 NON-KOR ACCESS KITS
    K850887 DRESSING CHANGE KIT
    K841742 NON-CORING NEEDLE
    K840919 DAYPAK SYS VII CATHETER CARE KIT
    K840681 DAYPAK SYSTEM III CATHETER CARE KIT