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

    PHOENIX HEMODIALYSIS DELIVERY SYSTEM

    K Number: K103832 · Decision May 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    13
    Review Days
    141

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    Basic Information

    Device Name
    PHOENIX HEMODIALYSIS DELIVERY SYSTEM
    K Number
    K103832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gambro Renal Products, Inc.
    Date Received
    December 30, 2010
    Decision Date
    May 20, 2011
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by Gambro Renal Products, Inc.

    K Number Device Name
    K133807 MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
    K131516 PRISMAFLEX SYSTEM 7.10
    K130039 REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
    K113313 MOLECULAR ADSORBENT RECIRCULATING(MARS)
    K110823 PRISMAFLEX
    K100451 GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
    K100364 GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
    K093608 GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
    K080519 PRISMAFLEX M150 SET
    K072232 GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
    Search all 13 clearances from Gambro Renal Products, Inc. →