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

    B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT

    K Number: K915482 · Decision Jan 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    632
    Review Days
    32

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    Basic Information

    Device Name
    B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
    K Number
    K915482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4430
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    December 6, 1991
    Decision Date
    January 7, 1992
    Product Code
    DWD
    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
    DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

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