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

    5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

    K Number: K041791 · Decision Sep 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    13
    Review Days
    70

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
    K Number
    K041791
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chf Solutions, Inc.
    Date Received
    July 2, 2004
    Decision Date
    September 10, 2004
    Product Code
    NQJ
    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
    NQJ Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NQJ), ordered by most recent decision date.

    Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    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
    K050609 AQUADEX SYSTEM
    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. →