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

    Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)

    K Number: K180950 · Decision Jun 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    29
    Review Days
    72

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    Basic Information

    Device Name
    Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
    K Number
    K180950
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corporation
    Date Received
    April 11, 2018
    Decision Date
    June 22, 2018
    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 Terumo Cardiovascular Systems Corporation

    K Number Device Name
    K234065 CDI OneView Monitoring System
    K221895 Terumo Advanced Perfusion System 1
    K200091 Capiox iCP Centrifugal Pump
    K182110 CDI Blood Parameter Monitoring System 550
    K172071 Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
    K172220 Advanced Perfusion System 1
    K163531 Advanced Perfusion System 1
    K162843 Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
    K160206 VirtuoSaph Plus Endoscopic Vessel Harvesting System
    K153376 Advanced Perfusion System 1
    Search all 29 clearances from Terumo Cardiovascular Systems Corporation →