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

    CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

    K Number: K130333 · Decision Mar 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    43
    Review Days
    30

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    Basic Information

    Device Name
    CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
    K Number
    K130333
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corp.
    Date Received
    February 11, 2013
    Decision Date
    March 13, 2013
    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 Corp.

    K Number Device Name
    K153140 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
    K133658 CDI BLOOD PARAMETER MONITORING SYSTEM 500
    K131041 ADVANCED PERFUSION SYSTEM 1
    K132451 SARNS SOFT-FLOW AORTIC CANNULA
    K133151 SARNS HIGH FLOW AORTIC ARCH CANNULA
    K130359 CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
    K123039 CDI BLOOD PARAMETER MONITORING SYSTEM 500
    K113214 TLINK DATA MANAGEMENT SYSTEM (DMS)
    K112587 ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
    K092789 VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
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