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

    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

    K Number: K153140 · Decision Dec 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    43
    Review Days
    33

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    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
    K Number
    K153140
    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
    October 30, 2015
    Decision Date
    December 2, 2015
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DTZ), ordered by most recent decision date.

    Lifemotion Disposable Membrane Oxygenator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Terumo Cardiovascular Systems Corp.

    K Number Device Name
    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
    K130333 CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
    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
    Search all 43 clearances from Terumo Cardiovascular Systems Corp. →