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

    QUADROX-IR ADULT AND SMALL ADULT

    K Number: K133265 · Decision Nov 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    82
    Applicant Total
    44
    Review Days
    20

    Basic Information

    Device Name
    QUADROX-IR ADULT AND SMALL ADULT
    K Number
    K133265
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MAQUET CARDIOPULMONARY AG
    Date Received
    October 23, 2013
    Decision Date
    November 12, 2013
    Product Code
    KFM
    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
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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    Other Clearances by MAQUET CARDIOPULMONARY AG

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    K141432 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
    K133598 CARDIOHELP SYSTEM
    K132166 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
    K132829 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
    K131666 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
    K130300 HEATER-COOLER UNIT HCU 40
    K123288 HEMOCONCENTRATOR
    K130639 ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
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