BEUDAMED
    Product Code: NIE FDA class 2 21 CFR 876.5540

    Catheter, Hemodialysis, Triple Lumen, Non-Implanted

    Gastroenterology, Urology

    The Triple Lumen Hemodialysis Catheter (Non-Implanted) is a short-term (less than 30 days) central venous access device used for hemodialysis and apheresis, with a third lumen available for infusion of medications or fluids. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIE and regulation 21 CFR 876.5540 in the Gastroenterology and Urology specialty. The device is flagged as life-sustaining/life-supporting due to its role in hemodialysis, and is not an implanted device given its short-term use.

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    510(k)s
    12
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    9
    Years Active
    22

    Basic Information

    Product Code
    NIE
    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

    Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 12 510(k) clearances via K numbers.

    K Number Device Name
    K232945 Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
    K222170 Power Acute Triple Lumen Hemodialysis Catheter
    K183219 Trio-CT Triple Lumen Catheter
    K181175 12F Tri-Flow Triple Lumen Catheter
    K143102 Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
    K141531 POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
    K133456 POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
    K123292 T3
    K102605 MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
    K083675 POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
    K033570 MEDCOMP T-3
    K020089 MAHURKAR TRIPLE LUMEN CATHETER, 12 FR

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.