Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153384
    Device Name
    Low Potassium Dextran Solution with Tris Diluent
    Date Cleared
    2016-02-19

    (88 days)

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

    United Therapeutics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Low Potassium Dextran Solution with Tris Diluent is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
    Device Description
    Low Potassium Dextran (LPD) Solution is a sterile, clear, non-pyrogenic, physiological salt solution for hypothermic flushing, storage, and transportation of human lungs outside the human body. LPD Solution is acidic and is adjusted shortly before use to pH 7.4 by the addition of Tris Diluent. LPD Solution with Tris Diluent is supplied as 1 liter of LPD Solution in a low density polyethylene (LDPE) bottle (8 per pack), co-packed with one single-use bottle of Tris Diluent. Tris Diluent is also supplied separately in an eight-unit pack. Each container of LPD Solution and Tris Diluent is single-use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1