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

    CATHETER CARE KITS

    K Number: K894611 · Decision Dec 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    148

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    Basic Information

    Device Name
    CATHETER CARE KITS
    K Number
    K894611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    L H M Ent., Inc.
    Date Received
    July 20, 1989
    Decision Date
    December 15, 1989
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by L H M Ent., Inc.

    K Number Device Name
    K901078 SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
    K901079 SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
    K894610 CUSTOM TRAYS, KITS
    K900439 SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
    K883506 IRRIGATION KIT