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510(k) Data Aggregation

    K Number
    K032068
    Device Name
    CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
    Manufacturer
    CARDIOVENTION, INC.
    Date Cleared
    2003-08-22

    (50 days)

    Product Code
    DTR, DTP, DTZ, KFM
    Regulation Number
    870.4240
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOVENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.
    Device Description
    The CORx IOS-200 System is a cardiopulmonary bypass system consisting of an oxygenator (870.4350), a non-roller-type cardiopulmonary bypass blood pump (870.4360), a heat exchanger (870.4240) and a blood circuit defoamer (870.4230)
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    K Number
    K030141
    Device Name
    MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
    Manufacturer
    CARDIOVENTION, INC.
    Date Cleared
    2003-02-26

    (42 days)

    Product Code
    DTQ
    Regulation Number
    870.4220
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOVENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours.
    Device Description
    The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device.
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    K Number
    K021694
    Device Name
    CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
    Manufacturer
    CARDIOVENTION, INC.
    Date Cleared
    2003-01-08

    (231 days)

    Product Code
    DTQ
    Regulation Number
    870.4220
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOVENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours.
    Device Description
    The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device.
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    K Number
    K012325
    Device Name
    CARDIOVENTION CORX SYSTEM, MODEL FG 0001
    Manufacturer
    CARDIOVENTION, INC.
    Date Cleared
    2002-04-09

    (260 days)

    Product Code
    KFM, DTP, DTZ
    Regulation Number
    870.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOVENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal gas exchange support. This device can be used with a legally marketed thermal requlating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting up to six hours. The CORx System is intended for use with Medtronic's Bio-medicus Bio-Console.
    Device Description
    The CardioVention CORx System is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The CardioVention CORx System consists of an active venous air removal device (defoamer), a centrifugal blood pump, a membrane oxygenator, an AirVac Controller and a pump adapter. The AirVac Controller powers the detection and facilitates removal of entrained air in the air handling system (defoamer) of the disposable unit. The pump adapter, which is magnetic, allows the use of the Medtronic Biomedicus Bio-Console (k941921) with the CORx System. The Medtronic's Biomedicus Bio-Console drives the CORx System's centrifugal pump. The following components of the CORx System disposable are provided sterile, for single use only: | Device | Description | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Defoamer (Air Removal) | A device that replaces the air removal<br>function of venous reservoirs by centralizing<br>venous line air and actively removing the air | | Centrifugal Blood Pump | An eight-vaned impeller (centrifugal) pump | | Oxygenator | A hollow fiber gas transfer device utilizing<br>polypropylene, double-mat, commercially<br>available fiber |
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