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

    SORB+HISORB+CARTRIDGE

    K Number: K031099 · Decision Sep 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    9
    Review Days
    163

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    Basic Information

    Device Name
    SORB+HISORB+CARTRIDGE
    K Number
    K031099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5600
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renal Solutions, Inc.
    Date Received
    April 7, 2003
    Decision Date
    September 17, 2003
    Product Code
    FKT
    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
    FKT System, Dialysate Delivery, Sorbent Regenerated

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    Other Clearances by Renal Solutions, Inc.

    K Number Device Name
    K123835 2008 HEMODIALYSIS SORBENT SYSTEM
    K121497 VENOFER PUMP
    K103564 VENOFER PUMP
    K093362 2008 HEMODIALYSIS SORBENT SYSTEM
    K093964 VENOFER PUMP
    K070739 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
    K060381 ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
    K043574 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000