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510(k) Data Aggregation

    K Number
    K010117
    Device Name
    GUIDANT AXIUS CORONARY SHUNT
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    2001-04-04

    (78 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983270
    Device Name
    VOYAGER QUAD CANNULA
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1999-07-28

    (314 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.
    Device Description
    The CTS Voyager Quad Cannula is a three lumen cannula with an elastomeric balloon near the distal tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The compliant balloon expands to occlude a range of aorta sizes. The large central lumen of the cannula serves to provide arterial perfusion. The side lumen serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid from the aortic root during cardiac surgery. The remaining lumen serves as a conduit for balloon inflation and deflation. The marker on the cannula outer shaft indicates the insertion depth. The clamp ring provided on the cannula allows the cannula to be fixed into position.
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    K Number
    K982419
    Device Name
    HEART-LIFT BALLOON POSITIONER
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1999-01-13

    (184 days)

    Product Code
    MWS
    Regulation Number
    870.4500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
    Device Description
    The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump, which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.
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    K Number
    K983135
    Device Name
    BLOWER/MISTER
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1998-11-13

    (66 days)

    Product Code
    FQH
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.
    Device Description
    The CTS Blower/Mister is comprised of a handpiece and malleable shaft enabling positioning of the device near the targeted site. Connectors on the device allow for hook-up to standard gas and saline sources. The device permits both an adjustable flow of gas and a mist of saline to be deposited at the targeted site.
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    K Number
    K963965
    Device Name
    CTS MIDCAB STITCHER
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1998-03-17

    (531 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.
    Device Description
    The Vascular Stitcher is a stainless steel surgical product designed for use with CTS compatible needle and suture in a semi-automatic or manually operated mode. The Vascular Stitcher is designed for use with or without trocar sleeves depending on the endoscopic technique or whether during minimally invasive surgical procedures.
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    K Number
    K970638
    Device Name
    CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1997-10-30

    (252 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS FloCoil Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.
    Device Description
    The CTS FloCoil Shunt consists of coil reinforced polymer shaft with a polymer seal on each end and tapered polymer tips. The polymer seals on each end contact the vessel wall and cause occlusion of the artery proximal and distal to the arteriotomy . The FloCoil Shunt is selected according to the outer diameter of the polymer seals and is available in various sizes for various vessel diameters. There is a hole in both tapered tip ends of the FloCoil Shunt to allow for the perfusion of blood through the shunt's inner lumen and beyond the arteriotomy. A polyester thread (tether) is attached to the FloCoil Shunt in the middle of the shaft. Attached to the tether is a radiopaque tab which is used to aid insertion and removal of the FloCoil Shunt.
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    K Number
    K963503
    Device Name
    CTS MIDCAB CORONARY SHUNT
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1997-04-03

    (212 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS MIDCAB Coronary Shunt is intended to be used during minimally invasive direct coronary artery bypass ("MIDCAB") procedures in conjunction with or without the CTS MIDCAB™ Access Platform and Stabilizer. The CTS Coronary Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This CTS Coronary Shunt is not an implant and is removed prior to completion of the surgery.
    Device Description
    The CTS MIDCAB Coronary Shunt is a hollow tube with atraumatic tips on each end and two seals which are utilized for proximal and distal occlusion of the artery. The atraumatic tips are tapered for easy insertion and removal from the artery. Each tip contains holes to provide for blood flow into and out of the CTS Shunt. The thread or tether is attached to a tab and is used to aid insertion and removal of the CTS Shunt. The blood is occluded and flows through the Shunt which reduces the blood in the operative field. Also included with the CTS MIDCAB Coronary Shunt is a Shunt Remover, which is a cylinder which can be used to withdraw the CTS Shunt following completion of the procedure.
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    K Number
    K963930
    Device Name
    CTS MIDCAB/SVH BIPOLAR SCISSORS
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1997-01-16

    (107 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTHORACIC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass ("MIDCAB") and saphenous vein harvesting procedures.
    Device Description
    The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument which consists of a pair of scissor blades which are connected to a handle instrument and an electrosurgical generator. Electric current flows from the electrode to the stainless steel cutting surface of the blades and from the stainless steel cutting surface of one blade to the stainless steel cutting surface of the other blade. The flow of the electric current down the electrode is controlled by the power generator. The overall length of the device, which consists of the handle, tube and blades, is approximately 13 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are approximately 0.5 inches in length. The surgeon places the opened scissors across the tissue to be cut and depresses the actuation lever while moving the scissors forward against the tissue. By energizing the power control unit on the actuation lever, the surgeon can simultaneously cut and coagulate the target tissue. Alternately, the power control unit may be controlled via a foot pedal. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting used for the CTS Bipolar Scissors is 20-30 watts. The CTS Bipolar Scissors is provided sterile, nonpyrogenic and for single use.
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