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

    FILTRYZER

    K Number: K940910 · Decision May 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    18
    Review Days
    433

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    Basic Information

    Device Name
    FILTRYZER
    K Number
    K940910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Toray Industries (America), Inc.
    Date Received
    February 25, 1994
    Decision Date
    May 4, 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 Toray Industries (America), Inc.

    K Number Device Name
    K042370 TORAYGUIDE GUIDEWIRE
    K030050 TORAYSULFONE DIALYZER, BS-L SERIES
    K002512 TORAYSULFONE DIALYZER
    K994198 HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
    K942681 FILTRYZER
    K935471 FILTRYZER(TM)
    K884339 TORAY FILTRYZER DIALYZERS
    K883407 TORAY FILTRYZER BK SERIES
    K884083 TORAY VASCULAR PROSTHESIS
    K882158 MODIFIED TORAY FILTRYZER DIALYZERS
    Search all 18 clearances from Toray Industries (America), Inc. →