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

    MCA(TM) 180 HEMODIALYZER

    K Number: K945622 · Decision May 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    27
    Review Days
    191

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    Basic Information

    Device Name
    MCA(TM) 180 HEMODIALYZER
    K Number
    K945622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Althin Medical AB an Affiliate of Baxter Intl
    Date Received
    November 15, 1994
    Decision Date
    May 25, 1995
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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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
    K970681 ALTRA NOVA 200 HEMODIALYZER
    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
    Search all 27 clearances from Althin Medical AB an Affiliate of Baxter Intl →