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Model BB811 and Model BB811-NS: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Model BB841: Oxygenator with Integrated Arterial Filter: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir: The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The 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), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The autoLog IQ autotransfusion system and Medtronic wash kit are in the collection, concentration, washing, and reinfusion of autologous blood. Areas of application may include, but are not limited to, the following: · Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and neurological · Postoperative treatment areas

The autoLog IQ Autotransfusion System is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. The system refers to the instrument (the subject of this submission); disposable devices are also required to operate the system: the Medtronic wash kit, collection reservoir, and suction line. This autologous blood is first filtered through the prefilter in the collection reservoir, and then processed by centrifugation, separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline, are pumped to a transfer bag, and may be reinfused to the patient. The autoLog IQ Autotransfusion System (also referred to as the "instrument" or the "system") is not patient contacting. However, the disposable devices needed to operate the system - the Medtronic wash kit, collection reservoir, suction line - are patient contacting, and are the same disposables used by the predicate autoLog Autotransfusion System device (K093535). The collection and concentration/washing of patient blood are handled independently by the system. The collection process requires the installation of a disposable reservoir and the activation and use of the integrated vacuum pump, which is built into the system, or an external vacuum source. The system has an integrated internal regulator which ensures safe vacuum levels. The blood is aspirated through a disposable collection suction tip/cannula and disposable suction line to the reservoir. Anticoagulant is delivered at the cannula through the anticoagulant line. The system's concentration/washing process requires the installation of the Medtronic wash kit and the activation and use of a pump, valve, and centrifuge. When the self-start switch registers a sufficient quantity of blood in the reservoir, the system automatically starts operation. The processing includes one cycle of filling the centrifuge bowl and concentrating the red cells (while transferring effluent waste to the waste bag), one cycle of washing the red cells with saline and one cycle of transferring the packed, washed red cells to the sterile holding bag. The pump pulls blood from the reservoir into the centrifuge bowl until the optical sensor detects a full bowl; then the roller pump stops and the wash solution is pumped into the packed red cell mass. After the washing cycle, the pump transfers the washed, packed red cells to the holding bag. Medical personnel complete the final reinfusion of the collected and washed blood to the patient. Hospital personnel are instructed to dispose the waste bag (containing plasma waste, saline, and contaminating debris) in accordance with hospital guidelines.

The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. The AF100 with Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.

MiRCSP Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the coronary sinus in a retrograde manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature manual and auto inflating cuffs, and contain an aid in verification of cannula placement. The removable malleable stylet is used to provide stiffness and shape to the cannula body during insertion and features additional deflectability and rotation at the distal cannula tip to aid in placement into the coronary sinus. These cannulae have features that make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thorocotomy).

The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Bio-Console® 560 is an extracorporeal blood pumping console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and Emergency Handcrank.

These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

The EOPA 3D™ Cannulae have clear flexible, thin wall wire-wound PVC bodies with a tapered distal tip. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The EOPA 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body has multiple depth markings, catalog code, and French size marked. Overall cannula length is 12.5" (31.8 cm). It will be available in 20 and 22 Fr sizes and either uncoated or with a Carmeda coating.

The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less

The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous Cannula and Introducer. The Cannula are one piece, wire wound bodies with basket type holes. Insertion depth marks aid in positioning the Cannula. All are supplied sterile, and non-pyrogenic and are single use. This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector. The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes. The Cannula are intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass. The overall product length is approximately 30.125 inches. The device is sterile, nonpvrogenic and disposable, and is intended for short-term single use. The product will be available in both Carmeda coated and uncoated versions.

This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

The MC2X™ Multi-Stage Venous Cannulae are cannula with with with an approximate The MC2X™ Multi-Stage Vehous Calimitat are camage and with an appoximate side ports in the distal tip, with ported arrial basket drainage and with an any side ports in the distal tip, with ported annor ousset online the cannula. All are overall length of 15 ¼". Insertion depth marks and in positioning the cannula. All are a overall length of 15 % . Insertion depth mains are single use. The devices may include a supplied sterile, are non-pyrogenic and are single use. The devices may include atte supplied sterile, are non-pyrogenc and are smgre ass. The artistion with tubing attached with a quick disconnect.

The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).