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The Frova Intubating Introducer is indicated to facilitate endotracheal intubation in patients where visualization of the glottis is inadequate e.g., as in grade II and III Cormack-Lehane views. This indication applies for introduction of a single lumen endotracheal tube with an inner diameter of 6 mm or larger. The Frova Intubating Introducer is also designed for transient oxygenation or jet ventilation in combination with 14 Fr compatible Rapi-Fit Adapters (15 mm and female Luer lock connector). The Rapi-Fit Adapters should only be used when oxygen requirements are high.

The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque introducer with centimeter markings and a blunt, curved tip that can be passed into the trachea. The introducer has a through lumen design with two distal sideports to ensure adequate airflow. The Frova Intubating Introducer can be supplied with a stiffening stylet and two Rapi-Fit® Adapters for connection to an oxygen source. The Frova Intubating Introducer is designed to facilitate airway intubation and allows for transient oxygenation and/or jet ventilation during the initial intubation. The Rapi-Fit Adapter with a 15 mm connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation during intubation. The Rapi-Fit Adapter with a female Luer lock connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation or jet ventilation during intubation. The stiffening stylet is intended to add rigidity to the proximal and middle sections of the introducer, while the distal portion remains flexible. The different configurations of the Frova Intubating Introducer are supplied sterile and are for single use only.

The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - · Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - · Failure of anticoagulant therapv in thromboembolic diseases: - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE. The Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - · Pulmonary thromboembolism when anticoaqulant therapy is contraindicated; - · Failure of anticoagulant therapy in thromboembolic diseases; - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced: and - · Chronic, recurrent PE where anticoaqulant therapy has failed or is contraindicated. The Celect Platinum Filter implant mav be retrieved if clinically indicated: please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or juqular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter. The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.

The Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.

Straight (TSMG-/-LES) and Curved (TSCMG-/-LES) Lunderquist® Extra Stiff Wire Guide. PTFE-coated stainless steel wire guides with lengths ranging from 90 cm to 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil for enhanced visibility. The J-curve radius for the curved wire guides is either 3 mm or 7 mm. Double curved (TSCMG-/-LESDC) and extended double curved (TSCMG-/-E-LESDC) Lunderquist® Extra Stiff DC Wire Guide. PTFE-coated stainless steel wire guides with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. TSCMG-/-LESDC has a primary/secondary curve radius on 75/15 mm, and TSCMG-/-E-LESDC has an extended primary/secondary curve radius on 55/15 mm. The Lunderquist® Extra Stiff Wire Guide is used both to assist in anatomical access for other devices (notincluded) and to support the delivery of medical devices. The wire guide is introduced into the target vessel; other devices, such as a sheath, catheter, stent, or endo vascular graft can then be passed over the wire guide to be positioned or manipulated within the vascular system. The Lunderquist® Extra Stiff Wire Guides are available in different lengths, shapes, etc. to accommodate different anatomical applications.

The Günther Tulip Filter implant is intended for the prevent pulmonary embolism (PE) via placement in the vena cava in the following situations: - · Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - · Failure of anticoagulant therapy in thromboembolic diseases; - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French predilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.

The Cook Celect Platinum Filter implant is intended or the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: ·Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - · Failure of anticoagulant therapy in thromboembolic diseases; - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Cook Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Cook Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Cook Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter.

The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.

The subject device, the Lunderquist Extra Stiff DC Wire Guide with an extended double curved tip, is considered a line extension of the predicate Lunderquist Extra Stiff DC Wire Guides. The subject device is a PTFE-coated 0.035 inch stainless steel wire with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. The length of the device is either 260 cm or 300 cm and the J-curve radius is 15 mm. The devices have the body and stiffness required to control large diameter, stiff devices without causing damage to the patient's anatomy or the lumen of the delivery system.

The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - Failure of anticoagulant therapy in thromboembolic diseases; - Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Günther Tulip Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each set consists of a preloaded filter, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Günther Tulip Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches; which includes a preloaded filter in the femoral approach. The Günther Tulip Vena Cava Filter is constructed from a cobalt chromium alloy. The end of each leg is hooked outward; this hook design enables securement of the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward the vein walls. These webs also increase the area into which emboli can be trapped. The filter is approximately 50 mm long along its main axis when compressed to a diameter of 30 mm.

The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; . - Failure of anticoagulant therapy in thromboembolic diseases; . - . Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - . Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Günther Tulip Vena Cava Filter Set is available in a femoral vein access version and in a universal vein access version consisting of components for both femoral and jugular vein approaches. Each set consists of a filter preloaded on the set for femoral approach, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Günther Tulip Vena Cava Filter is constructed from a cobalt chromium alloy. The end of each leg is hooked outward; this hook design enables securement of the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which emboli can be trapped. The filter is approximately 50 mm long along its main axis when compressed to a diameter of 30 mm.

The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; . - Failure of anticoagulant therapy in thromboembolic diseases; . - Emergency treatment following massive PE where anticipated benefits of conventional . therapy are reduced; and - . Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Cook Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of this booklet for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Cook Celect Platinum Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Cook Celect Platinum Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each set consists of a preloaded filter, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Cook Celect Platinum Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches. The Cook Celect Platinum Vena Cava Filter is constructed from a cobalt chromium alloy. Radiopaque markers constructed from a platinum tungsten alloy located on each primary leg enhance filter visibility on procedural imaging. The filter is approximately 49 mm long along its main axis when compressed to a diameter of 30 mm.

The Frova Intubating Introducer is intended to facilitate endotracheal intubation in patients where the visualization of the glottis in inadequate. The 14 French catheter has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.

The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque catheter introducer with centimeter markings and a blunt, curved tip that can be passed blindly into the trachea, when visualization of the glottis is inadequate and only visualization of the epiglottis can be confirmed by laryngoscopy. The catheter introducer has a tubular design with two distal sideports to ensure adequate airflow. It can be supplied with or without a stiffening stylet and/or two Rapi-Fit adapters for connection to a ventilator device. Pressure and flow specifications for the device when used for oxygenation are as follows: mean delivered minute volume is 8.6 L/min and mean measured average maximum airway pressure is 12.1 cm H2O (when input pressure is set to 50 psi, lung compliance is 100 mL/cm H2O, and resistance is 3 cm H2O/L/s). Incremental centimeter markings are placed on the shaft of the catheter introducer, with the first measurement marking designating 10 centimeters from the distal tip. The centimeter marks along the catheter shaft facilitate accurate depth placement of the catheter introducer into the airway.