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The Primi™ Support Catheter is intended to be used in conjunction with guidewires in order to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The support catheter also may be used to selectively infuse/deliver physician specified diagnostic and/or therapeutic agents, such as sterile saline, contrast agents, vaso-dilators, anti-blastics, lytics, and anti-thrombotics, with or without a guidewire in position.

The ThermopeutiX Support Catheter that is the submission is a single lumen catheter with a radiopaque marker that aids in positioning the catheter and a tapered tip to facilitate entry. The catheter utilizes an integral spine wire. The catheter is available in several diameters and lengths which are 0.014", 0.018", or 0.035" guidewire compatible. The working lengths are 90 cm thru 170 cm. Reference Table 1 for model number availability. The distal portion of the catheter shaft has a hydrophilic coating to facilitate insertion. The device has a luer hub connector to allow infusion of diagnostic and/or therapeutic agents. The device is supplied sterile and is intended for single use only. Reference Table 2 below for physical and performance characteristics.

The ThermopeutiX TAPAS™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The TAPAS™ Catheter is contraindicated for use in the coronary and intracranial arteries. The TAPAS™ Catheter is not intended for embolic protection or as an aspiration catheter.

Other than deletion of an optional extracorporeal circuit connection and the addition of a second balloon, the TAPAS™ catheter that is the subject of this submission is a substantially equivalent to the predicate ThermopeutiX DuoFlo catheter. The TAPAS™ catheter, as does the DuoFlo™ catheter, consists of two coaxial tubular shafts (inflow and outflow lumens) that can infuse diagnostic and/or therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are three additional smaller lumen is used for inflation of the distal balloon on the inflow lumen. one is for optional pressure monitoring and the third lumen permits inflation of the balloon on the outflow lumen.

The DuoFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The DuoFlo™ Catheter is contraindicated for use in the coronary and intracranial arteries. The DuoFlo™ Catheter is not intended for embolic protection or as an aspiration catheter.

The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.

The DuoFlo™ Catheter is intended for general intravascular use in the perioheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries. The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.

The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.

The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The VascuTraK™ II Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen terminating in a semi-compliant balloon. The catheter has a 24 cm lumen proximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The balloon is available in various diameters and lengths,