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

    ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

    K Number: K014016 · Decision Feb 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    33
    Review Days
    58

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    Basic Information

    Device Name
    ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
    K Number
    K014016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minntech Corp.
    Date Received
    December 5, 2001
    Decision Date
    February 1, 2002
    Product Code
    DWC
    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
    DWC Controller, Temperature, Cardiopulmonary Bypass

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