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

    MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

    K Number: K033262 · Decision May 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    24
    Review Days
    596

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    Basic Information

    Device Name
    MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
    K Number
    K033262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5870
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gambro Renal Products
    Date Received
    October 9, 2003
    Decision Date
    May 27, 2005
    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

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    K051520 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
    K052253 MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
    K043342 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
    K042797 WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
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