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

    DAYPAK SYSTEM III CATHETER CARE KIT

    K Number: K840681 · Decision Apr 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    7
    Review Days
    61

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    Basic Information

    Device Name
    DAYPAK SYSTEM III CATHETER CARE KIT
    K Number
    K840681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Creative Care Systems, Inc.
    Date Received
    February 15, 1984
    Decision Date
    April 16, 1984
    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 Creative Care Systems, Inc.

    K Number Device Name
    K861406 NON-KOR WINGED INFUSION SETS
    K852831 NON-KOR ACCESS KITS
    K850888 PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV
    K850887 DRESSING CHANGE KIT
    K841742 NON-CORING NEEDLE
    K840919 DAYPAK SYS VII CATHETER CARE KIT