BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Paragon Adult Maxi PMP Oxygenator with Tubing Pack

    K Number: K201642 · Decision Sep 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    3
    Review Days
    93

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    Basic Information

    Device Name
    Paragon Adult Maxi PMP Oxygenator with Tubing Pack
    K Number
    K201642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chalice Medical , Ltd.
    Date Received
    June 17, 2020
    Decision Date
    September 18, 2020
    Product Code
    DTZ
    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
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Chalice Medical , Ltd.

    K Number Device Name
    K231414 CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
    K191246 Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)