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510(k) Data Aggregation

    K Number
    K254305

    Validate with FDA (Live)

    Device Name
    BAROguard Donor Lung Preservation System
    Manufacturer
    Paragonix Technologies, Inc.
    Date Cleared
    2026-01-30

    (30 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Type
    Special
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Paragonix BAROguard is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.

    The intended organ storage time for BAROguard is up to 8 hours.

    Donor lungs exceeding clinically accepted static hypothermic preservation times 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.

    Note: Partial lungs can be transported via BAROguard by packaging lungs per institutional protocol and UNOS guidelines.

    Device Description

    Not Found

    AI/ML Overview

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