BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

    K Number: K242269 · Decision Nov 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    92

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    Basic Information

    Device Name
    SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
    K Number
    K242269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quanta Dialysis Technologies, Ltd.
    Date Received
    August 1, 2024
    Decision Date
    November 1, 2024
    Product Code
    ONW
    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
    ONW Hemodialysis System For Home Use

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    Other Clearances by Quanta Dialysis Technologies, Ltd.

    K Number Device Name
    K222067 SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
    K210661 SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
    K193670 SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set