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The CROSSER S6 System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

The CROSSER S6 System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER S6 Catheter. Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high-frequency mechanical vibrations which are propagated through a Nitinol core wire to the stainless steel tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

The FlowCardia FlowMate Injector is intended for use as a sterile saline injector for use as an accessory to the FlowCardia CROSSER CTO Recanalization System.

The FlowMate Injector is a sterile saline injector intended to be used as an accessory to the CROSSER CTO Recanalization System. The CROSSER System consists of a Generator, footswitch, and disposable catheter. The FlowMate Injector is designed to infuse saline at a rate of 0.3ml/sec (18 ml/min) at a maximum back pressure of 200 PSI. The FlowMate Injector is compatible for use with a 150ml disposable sterile syringe and is operated by a footswitch. A jumper cable is supplied with the FlowMate Injector to allow connection to the CROSSER System Generator. The FlowMate Injector is programmed to first start the Injector, and then the CROSSER System Generator each time the footswitch is depressed.

The CROSSER® System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER 14 Over the Wire Catheter. The CROSSER Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the Stainless steel tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

The CROSSER® System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Over the Wire Catheter is available in two variations: - CROSSER 14P OTW (014 guidewire compatible flexible), . - CROSSER 14S OTW (014 guidewire compatible supportive). . Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the Titanium tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

The MicroSheath LP is a single lumen catheter intended to create a pathway for other devices in the coronary or peripheral vasculature.

The FlowCardia MicroSheath LP a single lumen catheter, 123 cm in length, with a standard luer fitting at the proximal end. The catheter is available in two tip shapes, straight and angled. The distal tip is atraumatic to help facilitate vessel navigation. A single radiopaque marker on the straight version of the MicroSheath LP and five radiopaque markers on the angled version aid in fluoroscopic visualization. The MicroSheath LP is 6F Sheath/7Fr Guide compatible.

The CROSSER LP System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

The CROSSER System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER LP Catheter. Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high-frequency mechanical vibrations which are propagated through a Nitinol core wire to the stainless steel tip of the CROSSER LP Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

The MicroSheath XL is a single lumen catheter intended to create a pathway for other devices in the peripheral vasculature.

The FlowCardia MicroSheath™ XL is a single lumen catheter that is available in four lengths: 53cm, 73cm, 93cm or 123cm, and three different tip configurations: vertebral, internal mammary artery, and multipurpose. All MicroSheath XL catheters have a standard lucr fitting at the proximal end. A radiopaque distal tip aids in fluoroscopic visualization. The distal tip is atraumatic to help facilitate vessel navigation. The MicroSheath XL is also 7F Sheath compatible.

The CROSSER System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The CROSSER Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

The CROSSER System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Catheter is available in three sizes: - CROSSER 14P (014 guidewire compatible), . - CROSSER 14S (014 guidewire compatible supportive), . - CROSSER 18 (018 guidewire compatible). . Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high-frequency mechanical vibrations which are propagated through a Nitinol core wire to the Titanium tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

The VP Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The FlowCardia VP Wire is a steerable guide wire with an outer diameter of 0.014" and The FlowCardia VI Wire is a steerable gatus ATS y are constructed from a stainless steel available in 105 cm of 500 on overall rengths for each design. The proximal end of the core wire is coated with polytetrfluoroethylene (PTFE). A short radiopaque coil tip is soldered to the distal end of the core wire.