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

    GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER

    K Number: K994390 · Decision Oct 26, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    13
    Review Days
    303

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    Basic Information

    Device Name
    GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
    K Number
    K994390
    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 Healthcare
    Date Received
    December 28, 1999
    Decision Date
    October 26, 2000
    Product Code
    MSF
    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
    MSF Hemodialyzer, Re-Use, High Flux

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    Other Clearances by Gambro Healthcare

    K Number Device Name
    K990039 GAMBRO DQM 200
    K982413 COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
    K982414 GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
    K980386 HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)
    K982760 COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
    K982818 HOSPAL TIPSTOP
    K974899 GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
    K981681 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
    K981085 GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
    K970253 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
    Search all 13 clearances from Gambro Healthcare →