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The NC TREK NEO™ Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

NC TREK NEO is a Non-Compliant (NC), Rapid Exchange (RX), Coronary Dilatation Catheter (CDC). The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outside diameter (OD) of the distal end of the device, including the distal shaft, tip, and the balloon are coated with Hydrophilic Coating. Radiopaque markers are positioned on the inner member underneath the balloon to provide accurate positioning of the balloon in the artery. The balloon is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. The Single arm on proximal end of the device provides access to the inflation lumen. It is designed with a Luer-lock fitting to facilitate connection to an inflation device. The NC TREK NEO™ Coronary Dilatation Catheter will be available in select combinations of 1.50-6.00mm diameters and 6-25mm lengths.

The Viatrac 14 Plus Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arties) or for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

The Viatrac 14 Plus Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of the single lumen and dual lumen tubing. One lumen is used for the inflation of the balloon with a contrast medium. The second lumen in the distal shaft permits the use of a guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length at a specific pressure. On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral, or renal guiding catheter. An additional marker is located at the guidewire exit notch and aids in locating the guidewire exit notch.

This guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infrapopliteal arteries. This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The HI-TORQUE (HT) Proceed Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations. The HT Proceed Guide Wire Family will be available with the features as listed below: - 2 tip loads: 11g and 14g - 1 coating length: Uncoated Tip ● - 1 tip shape: Pre-shaped, micro-J ● - 2 lengths: 190 cm, 300cm The HT Proceed Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT Proceed Guide Wire Family has a maximum diameter of 0.0144". The distal tip has a radiopaque length of 3.0 cm.

The Hi-Torque Steelcore™ Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not in the cerebral vasculature.

The HT Steelcore Bare Guide Wire is classified under the product code DOX, with the regulation number 21 CFR 870.1330, Catheter guide wire. The HT Steelcore Bare Guide Wire is a steerable wire offered in only one configuration and is designed to be used with devices compatible with 0.018" guide wires. The HT Steelcore Bare Guide Wire is developed with 300 cm length and has a maximum diameter of 0.019". The distal tip has a radiopaque length of 5.0 cm. The HT Steelcore Bare Guide Wire will be available with the features as listed below: - Proximal Coating Single Coat Silicone Based hydrophobic coating. ● - Distal Coating Dual Coat Silicone Based Hydrophobic Coating. .

Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lession, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to crossing de novo chronic total coronary occlusions (CTO).

The HI-TORQUE (HT) InfilTrac Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations. The HT InfilTrac Guide Wire Family will be available with the features as listed below: - 2 tip loads: 11g and 14g - . 1 coating length: Uncoated Tip - 1 tip shape: Pre-shaped, micro-J - 2 lengths: 190 cm, 300cm The HT InfilTrac Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT InfilTrac Guide Wire Family has a maximum diameter of 0.0144". The distal tip has a radiopaque length of 3.0 cm.

The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the site of the Filtration Element should be between 2.5 and 7.0 mm.

The Emboshield NAVO Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during interventional procedures within carotid arteries or atherectomy in the arterial vasculature of the lower extremity. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element and RX Retrieval Catheter and ancillary items which include loading funnel, flushing syringes, introducer tool and torque devices.

The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only). The NC TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only) The TREK RX Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation. The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion: b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm -5.00 mm only). The MINI TREK RX Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO). The MINI TREK II OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction (MI); c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO).

The NC TREK RX Coronary Dilatation Catheter (CDC) is a medical device that is intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is provided on the proximal end of the catheter to provide access to the inflation lumen. It is designed with a Luer - lock fitting for connection with an inflation device. The NC TREK OTW Coronary Dilatation Catheter (CDC) is a medical device that is intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. NC TREK OTW is an over-the-wire co-axial design with a balloon at the distal tip. The outer lumen provides for inflation of the balloon with contrast medium. The inner lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The device has dual radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at specified pressures. The annular space between the outer member and the inner lumen provides a fluid path from the side arm adaptor to the balloon. The distal portion of the catheter is coated with a hydrophilic coating. The inner lumen of the inner member is coated with Microglide. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. A side arm adaptor is provided on the proximal end of the catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer - lock fitting for connection with an inflation device. The TREK and MINI TREK RX (CDC) are medical devices intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. They are both rapid exchange coaxial designs with a balloon at the distal tip. The MINI TREK sizes range from 1.20x6mm through 2.00x30mm. The TREK sizes range from 2.25x6mm through 5.00x15mm. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Balloon markers aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter's position relative to the guiding catheter tip when introducing the dilatation catheter through the guiding catheter. An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device. The annular space between the distal outer member and the central distal lumen provides a fluid path from the proximal lumen to the balloon. The shaft of the catheter, the tip, and tapers of the balloon are coated with a hydrophilic coating. The inner lumen of the inner member is coated with Microglide. The TREK OTW, MINI TREK OTW, and MINI TREK II OTW Coronary Dilatation Catheters (CDC) are medical devices intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. The TREK OTW family are over-the wire co-axial design catheters with a balloon at the distal tip. The MINI TREK OTW sizes range from 1.20x6mm through 2.00x30mm. The MINI TREK II OTW sizes range from 1.20x6mm through 2.00x20mm. The TREK™ OTW sizes range from 2.25x6mm through 5.00x15mm. The outer lumen provides for inflation of the balloon with diluted contrast medium. The inner lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Balloon markers aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter's position relative to the guiding catheter tip when introducing the dilatation catheter through the guiding catheter. An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer-lock fitting for connection with an inflation device. The annular space between the outer member and the inner lumen provides a fluid path from the side arm adaptor to the balloon. The outer shaft of the catheter, the tip, and tapers of the balloon are coated with a hydrophilic coating. The inner of the inner member is coated with Microglide.

The HI-TORQUE TurnTrac Guide Wire Family is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures. This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and /or reuse.

The HI-TORQUE (HT) TurnTrac Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip loads, hydrophilic coating lengths, tip shape and guide wire lengths. The HT TurnTrac Guide Wire Family will be available with the features as listed below: - 2 tip loads: 0.6g and 0.9g ● - 2 support levels: HT TurnTrac Moderate Support (MS) and HT TurnTrac Extra . Support (ES) - 2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ● - 1 tip shape: Straight ● - 2 lengths: 190 cm, 300cm ● The HI-TORQUE TurnTrac Guide Wire Family has a maximum diameter of 0.0142" or 0.0145" depending on the support level and is compatible with devices designed for use with 0.014" guide wires. The HI-TORQUE TurnTrac Guide Wire Family includes a shaping tool, which is clipped on to the outer packaging coil after the final assembled product has been inserted into the packaging coil. This accessory is to aid the physician in shaping the distal portion of the guide wire, if desired.

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box. The subject 510(k) pertains to a design change to the Steerable Guide Catheter. The proposed change to the Steerable Guide Catheter consists of a design and processing modification to the internal feature of the tip ring component at the distal tip.

This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Abbott Vascular Hi-Torque (HT) Command 18 Guide Wire with hydrophilic coating is a guide wire with a maximum diameter of 0.0180" and is provided in 210 cm and 300 cm lengths. The Abbott Vascular HT Command 18 Guide Wire consists of a 304V stainless steel proximal core and a nitinol distal core. The distal core is attached to the stainless steel proximal core using a dissimilar metal solid-state resistance weld. The core wire at the tip is flattened to provide optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. The HT Command 18 has a straight (shapeable) tip. The distal portion of the wire is covered with a polyurethane jacket and a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE) and a single coat of a silicone-based hydrophobic coating. Brachial and femoral markers are located on the proximal segment of the 210 cm and 300 cm guide wires.HT Command 18 Guide Wire is offered in two (2) packaging configuration options: With Accessory Devices (Torque Device and Guide Wire Introducer) and Without Accessory Devices.