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    K Number
    K944866
    Device Name
    VIASPAN (BELZER UW - CSS)
    Manufacturer
    THE DUPONT MERCK PHARMACEUTICAL CO.
    Date Cleared
    1996-04-22

    (567 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIASPAN (BELZER UW - CSS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Belzer UW Cold Storage Solution preserves organs, by cold storage, just as well as currently marketed media, such as Collins' solution. Belzer UW Cold Storage Solution, hereafter known as BELZER UW-CSS, can be used for cold storage of the liver, pancreas, and kidney. BELZER UW-CSS has the potential to be used as a general solution for most organs, both for initial cooling during in situ donor organ flushing and for subsequent cold storage.

    Device Description

    Not Found

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Device: BELZER UW Cold Storage Solution (BELZER UW-CSS)
    Purpose: Preservation of organs (liver, pancreas, kidney) by cold storage for transplantation.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by demonstrating equivalence or superiority to existing solutions (Collins' or EuroCollins' Solution - ECS) in terms of preservation time and post-transplant organ function.

    OrganAcceptance Criteria (Implicit)Reported BELZER UW-CSS Performance
    KidneyEquivalence/superiority to ECS in preserving kidneys for successful transplantation, including acceptable post-transplant renal function.Superiority: All dogs survived after kidney storage for 48-72 hours in BELZER UW-CSS, compared to 0% survival after 72 hours in ECS and 80% survival after 48 hours in ECS. Initial post-transplant renal function (serum creatinine) was better with BELZER UW-CSS.
    LiverEquivalence/superiority to ECS in extending preservation time and demonstrating comparable or improved post-transplant liver function.Superiority: Mean preservation time significantly longer (10.39 hours vs. 5.53 hours for ECS, p
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