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

    AQUADEX SYSTEM

    K Number: K050609 · Decision Nov 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    13
    Review Days
    244

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    Basic Information

    Device Name
    AQUADEX SYSTEM
    K Number
    K050609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chf Solutions, Inc.
    Date Received
    March 10, 2005
    Decision Date
    November 9, 2005
    Product Code
    KDI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by Chf Solutions, Inc.

    K Number Device Name
    K192756 Aquadex FlexFlow System 2.0
    K071854 AQUADEX FLEXFLOW SYSTEM
    K070512 MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
    K062922 MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
    K060008 AQUADEX FLEXFLOW SYSTEM
    K041791 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
    K040489 AQUADEX SYSTEM 100, MODEL A1100
    K031689 DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
    K023874 SYSTEM 100 ULTRAFILTRATION CATHETER
    K024124 SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
    Search all 13 clearances from Chf Solutions, Inc. →