Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K243870
    Device Name
    X°Port Lung Preservation System; X°Port Lung Preservation Solution
    Manufacturer
    Traferox Technologies Inc.
    Date Cleared
    2025-05-01

    (135 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Traferox Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X°Port Lung Preservation System: The X°Port Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient. The X°Port Lung Preservation System is intended to be used with the X°Port Lung Preservation Solution. The intended organ storage time for the X°Port Lung Preservation System is up to 8 hours. When clinically accepted static hypothermic preservation times are exceeded, the lungs should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient. X°Port Lung Preservation Solution: The X°Port Lung Preservation Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
    Device Description
    X°Port Lung Preservation System: The X°Port Lung Preservation System is an organ preservation system. It is designed to store, preserve, and transport human lungs donated for transplantation at 4°C-10°C. The X°Port Lung Preservation System consists of an insulated chamber, phase-change cooling packs, a cradle to hold the lung bag, and a temperature probe and logger. The X°Port Lung Preservation System is designed to be mobile, with wheels and a telescopic handle to maneuver the device throughout its travel. The device is designed to protect the lungs during transport and to display and log the internal temperature on an external screen. Additionally, the internal temperature may be monitored via an application running on a mobile device. X°Port Lung Preservation Solution: The X°Port Lung Preservation Solution is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. X°Port Lung Preservation Solution is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution. During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/or immediately after its removal. The solution is then left in the organ vasculature during hypothermic storage and transportation at 4-10°C. The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution must be supplemented with 0.5 mmol/l Calcium Chloride prior to use.
    Ask a Question
    K Number
    K240650
    Device Name
    LungProtect
    Manufacturer
    Traferox Technologies Inc.
    Date Cleared
    2024-11-26

    (264 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Traferox Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LungProtect is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
    Device Description
    LungProtect is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. LungProtect is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution. During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/ or immediately after its removal. The solution is then left in the organ vasculature during storage and transportation. The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution is packaged in one-liter (1000 ml) or two-liter (2000 ml) EVA bags, permanently and integrally connected to one (for 1L) or two (for 2L) PVC bags each containing 25 ml (1 mmol) THAM.
    Ask a Question

    Page 1 of 1