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510(k) Data Aggregation

    K Number
    K080169
    Device Name
    HEARTSTRING III PROXIMAL SEAL SYSTEM
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2008-02-08

    (15 days)

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

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
    Device Description
    The HEARTSTRING® III Proximal Seal System delivers a hemostatic seal device designed to enable the proximal anastomosis of an aortic graft without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery. The Proximal Seal System is comprised of the Proximal Seal, Delivery Device, Loader and the Aortic Cutter. The proximal Seal is a semi-spherical shaped device that is delivered into the aorta via the punch hole site and provides a sealed region to facilitate the proximal anastomosis. The Loader is a mechanism that rolls the Proximal Seal and loads the Seal into the Delivery Device. The Delivery Device is a plastic injected molded device that is used to deploy the Seal inside of the aorta. The HEARTSTRING® Aortic Cutter creates the aortotomy and hole opening in the aorta for the anastomosis.
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    K Number
    K041340
    Device Name
    GUIDANT MICROWAVE ABLATION SYSTEM
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2004-07-28

    (69 days)

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

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guidant Microwave Ablation System is indicated for the surgical ablation of soft tissue, and striated, cardiac, and smooth muscles. The System is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.
    Device Description
    The Guidant Microwave Ablation System consists of a microwave generator and handheld ablation probe accessories. The probe is available in two versions: the FLEX 4 and the FLEX 10. The ablation probe contains the microwave antenna that emits the microwave energy. The microwave generator's output (2450 MHz) is conducted through the output cable, into the cabling of the Probe, and out the antenna at the distal section of the Probe. Energy is expressed in a pattern that is radial to the orientation of the ablating tip. Shielding in the ablating tip inhibits microwave energy expression into non-targeted tissue. The target tissue contains polar molecules (most notably water), which vibrate in response to the induced electromagnetic microwave field. This vibration creates heat through friction, raising the temperature of the tissue throughout the area being ablated. Upon reaching a certain temperature, the tissue becomes necrotic, and thus fully ablated. FLEX 4 has a flexible antenna fixed at the distal end of the probe. FLEX 10 has a flexible antenna that can be moved along the distal end of the probe.
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    K Number
    K023630
    Device Name
    ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2003-02-20

    (115 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESSeX Aspiration/Irrigation and Positioning Guide is intended for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid to and from the operative site, localizing and removal of irrigation, feeding, drainage, and chest tubes.
    Device Description
    The ESSeX Aspiration/Irrigation Instrument with Positioning Guide is a reusable stainless steel irrigation/aspiration instrument with a positioning guide. The instrument is designed to for use during endoscopic surgical procedures. ESSeX Aspiration/Irrigation Instrument with Positioning Guide is The manufactured from surgical grade stainless steel. The instrument has an overall operating length of 35.6cm and an outer diameter of 7.5 mm. The instrument functions as a standard suction/irrigator and provides for the localization and removal of a variety of irrigation, feeding, drainage, and chest tubes. The positioning quide component of the instrument is attached in such a manner that allows for the delivery or capture of irrigation or drainage tubes.
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    K Number
    K024071
    Device Name
    GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2003-02-14

    (66 days)

    Product Code
    NHW
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.
    Device Description
    The Syncrus System consists of three components: - Three temporary heart wires sutured onto the heart during open-heart surgery. The wires include a unipolar defibrillation heart wire (left atrium), a bipolar pacing/sensing heart wire (right or left ventricle) and a tripolar defibrillation and pacing and sensing heart wire (right atrium). - An attenuator box (External Defibrillator Interface Module EDIM). The EDIM attenuates the delivered energy from a standard, low energy defibrillator by 97% (50 - 360 Joules to 1.3 - 11.5 Joules). - A cardioversion extension cable, which connects the defibrillation heart wires to the EDIM. The user must supply an external, low-energy defibrillator that is capable of synchronized cardioversion, an external pacemaker, and temporary patient cables to connect the pacemaker to the patient. The Syncrus System is designed to perform the following cardiac rhythm management functions: - Atrial pacing and electrocardiogram sensing - Ventricular pacing and electrocardiogram sensing - Atrial defibrillation using low energy, synchronized cardioversion.
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    K Number
    K023629
    Device Name
    ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2002-11-12

    (15 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Essex Dissection Cannula is intended for use in dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures. The Essex Dissection Cannula is indicated for dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures including percutaneous thoracic and pericardial surgery.
    Device Description
    The Essex Dissection Cannula is a reusable device designed for dissection of tissue and introduction of instruments for visualization and manipulation during endoscopic surgical procedures. The device consists of two tubular cannulae for introduction of instrumentation into the surgical site. One lumen allows insertion of an endoscope for illumination and visualization of the procedure. Another lumen provides access for surgical instruments. A disposable Dissection Tip may be attached to the end of the cannula for dissection of tissue.
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    K Number
    K022718
    Device Name
    VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2002-08-28

    (13 days)

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

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoView® 6 Harvesting Cannula is intended for cutting and coagulation of tissue and providing access in minimally invasive vessel harvesting procedures for patients undergoing coronary artery bypass grafting. The VasoView® 6 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
    Device Description
    The VasoView 6 Harvesting Cannula is a disposable device designed to perform endoscopic cutting and coagulation, including vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Extension, retraction and actuation of the transector cutting and coagulation tool is achieved with controls located on the handle.
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    K Number
    K020701
    Device Name
    SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2002-05-24

    (81 days)

    Product Code
    NHW
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guidant Syncrus™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.
    Device Description
    The Syncrus Heart Wires and Connectors are used for atrial and ventricular pacing and electrocardiogram sensing to diagnosis and treat atrial (type I) flutter and some forms of tachycardia. The wires are also used to treat post-operative arrhythmias, particularly atrial fibrillation, when used in conjunction with the Syncrus Cardioversion Extension Cable and Syncrus External Defibrillator Interface Module (EDIM). The EDIM is a passive device. The EDIM when used with a compatible external monophasic defibrillator reduces the energy to approximately 3% and delivers the low-energy cardioversion shock directly to the atria. The cardioversion is achieved by delivering a synchronized electrical pulse of approximately 11.1 Joules or less to the atrial chambers of the heart. There are three types of Heart Wires: - A tripolar atrial wire, capable of pacing and sensing, and cardioversion, when used in conjunction with the unipolar wire. - A unipolar atrial wire, capable of cardioversion when used in conjunction with the cardioversion electrode on the tripolar wire. - A bipolar ventricular wire, capable of pacing and sensing. The wires are comprised of curved needle(s), attached to lead(s) on the proximal end. The wires are insulated for long length. A straight needle is attached to the leads on the distal end of the wires. Cardioversion connectors are provided that attach to the appropriate heart wire leads. Pacing connector pins are pre-assembled onto the appropriate heart wire leads. The Syncrus Heart Wires are intended to be affixed to the surfaces of their respective heart chambers, during or immediately following open-heart surgery, before the median sternotomy is closed. Temporary pacing heart wires are routinely implanted in a similar manner. The unipolar atrial wire is placed on the left atrium, the tripolar atrial wire is placed on the right atrium, and the bipolar ventricular wire is placed on either ventricle. If all of the Heart Wires are implanted, the atrial and ventricular temporary sensing and pacing ability can be used, and only if the patient develops post-operative AF would the cardioversion feature be used. Both the unipolar atrial wire and the tripolar atrial wires are required in order to perform a cardioversion. When only the capability to treat post-operative AF is desired, the ventricular wire is not required. When the pacing feature is used, the pacing lead is inserted into the myocardial tissue of the atrium using the curved needles. Location and pattern of the lead is not critical, as the lead simply requires tissue contact. The "bullet" (define) on the ground wire is then pulled through the hole formed by the curved needle, and is thus buried in the myocardial wall.
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    K Number
    K020143
    Device Name
    VASOVIEW 5 HARVESTING CANNULA
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Date Cleared
    2002-02-20

    (35 days)

    Product Code
    HET, GEI
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CORPORATION, CARDIAC SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoView 5 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
    Device Description
    The VasoView 5 Harvesting Cannula is a disposable device designed to perform endoscopic vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Opening, closing, extension and retraction of the scissors blades is actuated via controls on the handle.
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