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The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the illac, femoral, iliofemoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Tri-Wedge PTA Scoring Balloon Dilatation Catheter is an over-the-wire (OTW) peripheral balloon dilatation catheter. The catheter working length is 50cm, 75cm, 90cm and 150cm. Balloon diameters range from 3.0mm to 8.0mm. The balloon is made of a minimally compliant material with rated burst pressure of 20atm for Ø3.0-6.0mm and 16atm for Ø7.0-8.0mm. A coaxial double lumen catheter for balloon inflation and guide wire insertion is bonded to a female luer connector to form the proximal shaft. The balloon and the coaxial double lumen are welded to compose the distal of the catheter surface is coated with hydrophilic coating from the tip to the distal shaft. A scoring element with three parallel struts wraps around the balloon has radiopaque markers for positioning the balloon relative to the stenosis. The guide wire lumen is compatible with a standard 0.018-inch or 0.035-inch guide wire that enters from the catheter and extends out from the hub. The catheter is sterilized with EO and for single use only.

The POT PTCA balloon dilatation catheter is 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 coronary artery occlusion for the treatment of acute myocardial infarction - balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only) Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible Nylon balloon at its distal tip. It is typically a rapid exchange (Rx) type with a single-lumen catheter. It is a single-use device and available in various sizes.

The balloon dilatation catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, poplited, tibial, peroneal, subclavian and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Tiche is an Over the Wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The device features a low profile balloon and tip. The working length of the catheter range from 40cm-135cm. A hydrophilic coating is applied from the distal shaft. The balloon dilatation catheter features a dual lumen shaft ending in a Y-hub manifold. The balloon has two radiopaque markers for positioning the balloon relative to the stenoses. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The balloon dilatation catheter is intended to dilate stenoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC (0.035") PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The catheter working length is 70, 90 and 150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work length range from 10mm to 150mm. The three PTA balloon dilatation catheters are filed in one 510(k) submission due to the similar/equivalent construction and identical material of the products. The comparison of them was summarized in Table 1. The differences only exist in the guide wire compatibility and the balloon configuration which have been controlled by the Design Verification. The balloon material is made of a non-compliant Nylon material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The three products of the non-compliant PTA (OTW type) balloon catheter family have different diameter of the guide wire port from max.0.014" to 0.035". The guide wire compatibility was shown in table 1. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The balloon dilatation catheter is 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 coronary artery occlusion for the treatment of acute myocardial infarction - balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

The Apollo Balloon Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guidewire. Balloon diameters range from 2.0mm to 5.0mm. The balloon material is made of a minimally compliant material with a rated burst pressure of 22 atmospheres for Ø2.0- 4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively. The minimally compliant balloon material will allow high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube of nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm in length located on the proximal shaft, indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters are over-the-wire (OTW) peripheral balloon catheters designed for Percutaneous Transluminal Angioplasty (PTA). These three PTA balloon dilatation catheters have been bundled in one 510(k) submission due to the similar/equivalent construction and identical material of the products. As summarized by the comparison between the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters in Table 1, the devices only differ in guidewire compatibility, balloon diameter, and balloon length. The devices are offered with catheter working lengths of 70, 90 and 150 cm. The guidewire compatibility includes 0.014" for the Polux device, 0.018" for the Minerva device and 0.035" for the Atropos device. The balloon diameters range from 1.5 mm to 10.0 mm, with balloon working lengths ranging from 5 mm to 200 mm. The balloon material is made of a semi-compliant Pebax material and offered in diameters 1.5 mm to 10.0 mm with a rated burst pressure of 14 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter depending on the pressure delivered. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The Apollo Balloon Dilatation Catheter is indicated for: 1.The balloon dilatation catheted for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion 2.Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction 3.Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only) Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

The Apollo Balloon Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guidewire. Balloon diameters range from 2.0mm to 5.0mm. The balloon material is made of a minimally compliant material with a rated burst pressure of 22 atmospheres for Ø2.0-4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively. The minimally compliant balloon material will allow high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube of nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm in length located on the proximal shaft, indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The Artimes Balloon Dilatation Catheter is indicated for: 1. Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients coronary ischemia for the purpose of improving myocardial perfusion 2. Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

The Artimes1 (Rx type) device is a coronary dilatation catheter designed for easy guidewire exchange. The catheter working length is 140cm. Lubricious coatings are applied to the distal section. Balloon diameters range from Ø1.5mm to Ø4.0mm. The balloon material is made of a semi-compliant Pebax material for diameter 1.5mm to 4.0mm with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube with a wire. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of pebax/nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of balloon diameters less than 2.0mm which incorporate a centrally positioned single marker band. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. Note 1: the Artimes balloon dilatation catheter family contains Ø1.0-1.25mm x 5-30mm configurations which are NOT intend for sales in the United States (US) but rest of world (ROW) based upon availability of regulatory approvals. Separate Catalog numbers have been assigned to the Artimes US product (801-DDLLU, reference section 11.0) for the Ø1.5-4.0mm x 5-30mm configurations with its IFU and label, compared with Artimes ROW product (801-DDLL) for the Ø1.0-4.0mm x 5-30mm configurations. Additional 510k or relevant (e.g. IDE or PMA) submission will be executed if BrosMed Medical is going to registry those configurations (Ø1.0-4.0mm x 5-30mm) in the United States.