BEUDAMED
    Product Code: NQJ FDA class 2 21 CFR 876.5540

    Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

    Gastroenterology, Urology

    The non-implanted peripheral ultrafiltration hemodialysis catheter is a dual-lumen catheter inserted into a peripheral arm vein for temporary ultrafiltration (up to 8 hours) to treat patients with fluid overload, providing a non-central-access route for the procedure. It is classified as FDA Class 2 under regulation 876.5540 in the Gastroenterology and Urology specialty, requiring 510(k) clearance, and carries a life-sustaining flag. Product code NQJ is not eligible for third-party review.

    View on FDA
    510(k)s
    4
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    2
    Years Active
    22

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    Basic Information

    Product Code
    NQJ
    Device Class
    FDA class 2
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K252226 Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
    K233515 Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
    K041791 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
    K031689 DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.