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

    ALTRA NOVA 200 HEMODIALYZER

    K Number: K970681 · Decision Jul 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    27
    Review Days
    514

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    Basic Information

    Device Name
    ALTRA NOVA 200 HEMODIALYZER
    K Number
    K970681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Althin Medical AB an Affiliate of Baxter Intl
    Date Received
    February 24, 1997
    Decision Date
    July 23, 1998
    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 Althin Medical AB an Affiliate of Baxter Intl

    K Number Device Name
    K990643 PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
    K970679 ALTRA FLUX 200 HEMODIALYZER
    K970446 DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
    K964922 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
    K955384 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
    K962309 ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
    K954987 ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
    K952978 ALTRA FLUX 110 HEMODIALYZER
    K952983 ALTR NOVA 110 HEMODIALYZER
    K952982 ALTREX 110 HEMODIALYZER
    Search all 27 clearances from Althin Medical AB an Affiliate of Baxter Intl →