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

    Advanced Perfusion System 1

    K Number: K153376 · Decision Dec 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    51
    Applicant Total
    29
    Review Days
    23

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    Basic Information

    Device Name
    Advanced Perfusion System 1
    K Number
    K153376
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corporation
    Date Received
    November 23, 2015
    Decision Date
    December 16, 2015
    Product Code
    DTQ
    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
    DTQ Console, Heart-Lung Machine, 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
    K180950 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)
    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
    Search all 29 clearances from Terumo Cardiovascular Systems Corporation →