BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KPS-I, THE KIDNEY PERFUSION SOLUTION

    K Number: K013575 · Decision Jan 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    42
    Applicant Total
    4
    Review Days
    88

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    Basic Information

    Device Name
    KPS-I, THE KIDNEY PERFUSION SOLUTION
    K Number
    K013575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Organ Recovery Systems, Inc.
    Date Received
    October 29, 2001
    Decision Date
    January 25, 2002
    Product Code
    KDN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDN System, Perfusion, Kidney

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    Other Clearances by Organ Recovery Systems, Inc.

    K Number Device Name
    K091656 SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
    K021362 LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
    K022391 MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION