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

    MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

    K Number: K133807 · Decision Mar 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    13
    Review Days
    100

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    Basic Information

    Device Name
    MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
    K Number
    K133807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5870
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gambro Renal Products, Inc.
    Date Received
    December 16, 2013
    Decision Date
    March 26, 2014
    Product Code
    FLD
    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
    FLD Apparatus, Hemoperfusion, Sorbent

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    Other Clearances by Gambro Renal Products, Inc.

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    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. →