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

    FURUI SHUNT, 2-WAY AND 3-WAY

    K Number: K910004 · Decision Sep 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    2
    Review Days
    260

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    Basic Information

    Device Name
    FURUI SHUNT, 2-WAY AND 3-WAY
    K Number
    K910004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Theramed, Inc.
    Date Received
    January 2, 1991
    Decision Date
    September 19, 1991
    Product Code
    DWF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Theramed, Inc.

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    K895524 HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.