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

    LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

    K Number: K021362 · Decision Jul 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    42
    Applicant Total
    4
    Review Days
    457

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    Basic Information

    Device Name
    LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
    K Number
    K021362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Organ Recovery Systems, Inc.
    Date Received
    April 30, 2002
    Decision Date
    July 31, 2003
    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
    K022391 MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
    K013575 KPS-I, THE KIDNEY PERFUSION SOLUTION