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

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

    K Number: K233515 · Decision Dec 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
    K Number
    K233515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuwellis, Inc.
    Date Received
    November 1, 2023
    Decision Date
    December 26, 2023
    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

    5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

    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 Nuwellis, Inc.

    K Number Device Name
    K252226 Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)