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

    TERUMO PALL AL20X ARTERIAL FILTER

    K Number: K121209 · Decision May 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    29
    Review Days
    18

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    Basic Information

    Device Name
    TERUMO PALL AL20X ARTERIAL FILTER
    K Number
    K121209
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corporation
    Date Received
    April 20, 2012
    Decision Date
    May 8, 2012
    Product Code
    DTM
    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
    DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

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    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 →