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The Amethyst HP PTA OTW 0.035" catheter is indicated for: - Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. - Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature

The Amethyst HP PTA OTW 0.035 catheter is a balloon catheter consisting of an over the wire catheter with a non-compliant inflatable balloon fixed at the distal end of the tip. The balloons are designed to provide consistent balloon diameters and lengths at high pressures. A radiopaque tapered tip positioned at distal of the balloon facilitates the advancement of the catheter to and through the stenosis. A Luer lock fitting (Y hub) at the proximal end allows connection with an inflation device. The catheter is a co-axial catheter with a balloon at the distal tip. One lumen is used for the inflation of the balloon and is accessed via the lateral port of the Y hub. The second lumen, start at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The balloon has two radiopaque markers to aid in positioning the balloon relative to stenosis. The balloon is dilated using the lateral port, at which the balloon opens to a known diameter at a specific pressure. The maximum recommended guide wire diameter is 0.035". The catheter is supplied sterile and is intended for single use.

The Ebony HP PTA OTW 0.035" Catheter is indicated for; · Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. · Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Ebony HP PTA OTW 0.035" Catheter is a standard Over The Wire (OTW) PTA catheter with a non-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end to facilitate advancement of the catheter through the stenosis, and a luer lock fitting (Y hub) at the proximal end allowing the connection with an inflation device. The catheter is a two lumen catheter; one lumen is used for inflation of the balloon and accessed via the lateral port of the Y hub. The second lumen, starting at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The maximum recommended guide wire diameter is 0.035". The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. The working pressure range for the balloon is between the nominal pressure (NP) and the rated burst pressure (RBP). A hydrophilic coating solution is applied on the distal section of the shaft and on the balloon to improve the pushability of the catheter by reduction of the friction coefficient of the outer body.

The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

The Tamarin Blue PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter. The device is supplied sterile and intended for one-time use.

The Filao NC RX PTCA Dilatation Catheters are indicated for: Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion. Balloon dilatation of a stent after implantation (balloon models 2.00mm - 4.50mm)

The Filao NC RX PTCA Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a non-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenosis. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating improves pushability of the catheter. The Filao NC PTCA RX Catheter is available in balloon diameters ranging from 2.00 mm to 4.50 mm, and balloon lengths ranging from 8mm to 30 mm in step of 1 mm. The maximum recommended guide wire diameter is 0.014"

The Ebony® PTA 0.014" over the wire Catheter is intended for dilatation of lesions in the femoral, popliteal and infrapopliteal arteries. The Ebony® PTA 0.014" over the wire Catheter is contraindicated for use in coronary arteries or neuro-vasculature. The Ebony® PTA 0.018" over the wire Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony® PTA 0.018" over the wire Catheter is not for use in coronary arteries or neuro-vasculature.

The Ebony ® PTA 0.014" over the wire catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated. Maximum guide wire diameter is 0.014" (0.36 mm). The usable catheter length for OTW is 120 cm and 150 cm. In order to correctly position the balloon under fluoroscopy, two radiopaque markers are placed on the shaft under the balloon itself, defining its cylindrical area. The catheter includes a smooth, soft and atraumatic tip to facilitate advancement of the catheter through the stenosis. In order to facilitate advancing through the vasculature, a hydrophilic coating is present on the distal shaft and the balloon. The Ebony ® PTA 0.014" over the wire catheter is available in 2 usable lengths: 120 and 150 cm; and in the balloon sizes shown in Table 1. The Ebony ® PTA 0.014" over the wire catheter will be supplied sterile and is intended for one time use. The Ebony® PTA 0.018" over the wire Catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated and it ends at the tip of the catheter. Maximum guide wire diameter is 0.018" (0.46 mm). 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. The Ebony® PTA 0.018" over the wire Catheter is available in two catheter lengths and the balloon sizes shown in Table 2 below. The Ebony® PTA 0.018" over the wire Catheter is supplied sterile and is intended for one time use.

The Ebony® PTA .035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal & renal arteries. The Ebony® PTA . 035'' OTW Peripheral Dilatation Catheter is not for use in the coronary arteries and neuro-vasculature.

The Ebony® PTA 0.035 Peripheral Dilatation Catheter is a standard Over The Wire (OTW) PTA catheter with a semi-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature. The modified Ebony® PTA 0.035 Peripheral Dilatation Catheter line extension adds 3.0 mm and 4.0 mm diameter balloon and additional balloon lengths to the currently available sizes.

The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not intended for use in coronary or neuro-vasculature.

The EBONY® PTA 0.014" RX Dilatation Catheter is a standard rapid exchange (RX) PTA catheter with a semi-compliant inflatable balloon and tapered tip on the distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature. The modified EBONY® PTA 0.014" RX Dilatation Catheter line extension adds a 1.5 mm diameter balloon and additional balloon lengths to the currently available sizes.

The Tamarin Blue® RX PTCA Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

The Tamarin Blue® PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. The balloon material expands to a known diameter at specific pressure as defined in the compliance table supplied with the catheter.

The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries. This catheter is not for use in coronary or neuro-vasculature.

The Ebony® PTA 0.014'' Peripheral Dilatation Catheter is a standard Rapid Exchange (RX) PTA catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenoses. The catheter is double lumen in the distal part, one lumen is used for inflation and deflation of the balloon, and the second lumen allows access to the distal part of the catheter for guide wire insertion (max. 0.014"). The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows the connection with an inflation device. The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. An hydrophilic coating solution is applied on the catheter body to improve the pushability of the catheter by reduction of the friction coefficient of the outer body. The balloon material expands to a known diameter at specific pressure defined in a compliance table supplied with the catheter. The device is available in balloon diameter of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 mm, and balloon lengths of 10, 15, 20, 25, 30, 35, 40, and 60 mm. It will be supplied sterile and is intended for one time use.

The Ebony® .035 PTA Catheter is intended for the dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony® .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.

The Ebony® PTA .035 Peripheral Dilatation Catheter is a standard Over the Wire (OTW) PTA Catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing tight stenoses. It is a double lumen catheter, one lumen for the guide wire used for inflation/deflation of the balloon and one lumen for the guide wire used to access to the distal tip of the catheter (max/0.035″). A luer lock fitting allows the connection with an inflation device (Y hub). The balloon has two radiopaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. The distal catheter, proximal to the balloon, is covered with a hydrophilic coating to improve the trackability and pushability characteristics. The balloon material expands to a known diameter at specific pressure defined in a compliance chart supplied with the catheter. The device is available in balloon. diameters of 5, 6, 7, 8, 9, 10 or 12 mm, balloon lengths of 20, 40, 60, or 80 mm and catheter lengths of 80, 130, or 150 cm. lt will be supplied sterile and is intended for one time use.