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510(k) Data Aggregation

    K Number
    K150472
    Device Name
    NxStage System One
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2015-06-04

    (101 days)

    Product Code
    ODN
    Regulation Number
    876.5860
    Why did this record match?
    Product Code :

    ODN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for home hemodialysis, including home nocturnal hemodialysis. All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
    Device Description
    The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.
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    K Number
    K141752
    Device Name
    NXSTAGE SYSTEM ONE
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2014-12-19

    (172 days)

    Product Code
    ODN
    Regulation Number
    876.5860
    Why did this record match?
    Product Code :

    ODN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for home hemodialysis, including home nocturnal hemodialysis. All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
    Device Description
    The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.
    Ask a Question

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