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510(k) Data Aggregation

    K Number
    K140841
    Device Name
    TABLO CARTRIDGE
    Manufacturer
    HOME DIALYSIS PLUS
    Date Cleared
    2014-09-11

    (162 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIALYSIS PLUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tablo™ Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Tablo™ Cartridge is compatible only with the Tablo™ Hemodialysis System.
    Device Description
    The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.
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    K Number
    K140866
    Device Name
    TABLO CONSOLE
    Manufacturer
    HOME DIALYSIS PLUS
    Date Cleared
    2014-09-10

    (160 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOME DIALYSIS PLUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tablo™ System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trailable as needed who is considered competent in the use of the device by the prescribing physician.
    Device Description
    The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration. The Tablo Console consists of a conventional Dialysis Delivery System (DDS; Upper Module) and a compact Water Purification System (WPS; Lower Module). The Dialysis Delivery System (Upper Module) and the Water Purification System (Lower Module) are stacked and latched together to form a single integrated Console.
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