LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061782
    Device Name
    GAMBRO POSICLEAR
    Manufacturer
    GAMBRO SERVICES, INC.
    Date Cleared
    2007-01-04

    (192 days)

    Product Code
    FIP
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMBRO SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gambro Posiclear filter is intended to remove bacteria, endotoxin, and particulate matter from water used for hemodialysis. It is intended for use in dialysis water treather systems as a final stage of filtration after RO or DI treatment to help control bacteria and endotoxin levels in purified water distribution systems. This filter is not intended as a primary means of water purification for hemodialysis
    Device Description
    The Gambro Posiclear filter consists of a encapsulated, micro porous pleated nylon membrane in a polypropylene housing designed to filter endotoxins, bacteria and particulates from water intended to be used for hemodialysis
    Ask a Question

    Page 1 of 1