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

    FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

    K Number: K970700 · Decision Sep 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    38
    Review Days
    567

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
    K Number
    K970700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fresenius USA, Inc.
    Date Received
    February 25, 1997
    Decision Date
    September 15, 1998
    Product Code
    MSE
    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
    MSE Hemodialyzer, Re-Use, Low Flux

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MSE), ordered by most recent decision date.

    PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ASAHI AM-R SERIES DIALYZERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Fresenius USA, Inc.

    K Number Device Name
    K992275 FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
    K974584 FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
    K973378 C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
    K961465 2008H ON LINE CLEARANCE MONITOR
    K961706 P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
    K955762 PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
    K941460 FRESENIUS BLOOD TEMPERATURE MONITOR
    K955423 PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
    K944767 DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
    K930181 BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE
    Search all 38 clearances from Fresenius USA, Inc. →