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The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for: • balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm configurations) is indicated for: • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion • balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction The Sapphire® II PRO Balloon Dilatation Catheter is also indicated for: • percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO Balloon Dilatation Catheter is now also available as an over-the-wire balloon catheter with a working length of 150cm. The semi-compliant balloons are available in diameters from 1.0-1.25mm and lengths from 5-15mm with a rated burst pressure of 14 atmospheres. The catheter consists of proximal section with a Y-type hub and distal section with a balloon near the distal tip. The straight port of the hub is the guidewire entrance and the side port is used to inflate and deflate the balloon. The external lumen provides for inflation of the balloon with dilute contrast media solution. The internal lumen permits the use of a standard 0.014 inch guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. Hydrophilic lubricious coatings are applied to the distal section. One radiopaque platinum marker band is located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters and 4F or larger guiding sheaths. Two marked sections (3mm in length) are located on the proximal shaft to indicate catheter position relative to the tip of either guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The Sapphire NC Plus Coronary Dilatation Catheter is indicated for: · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion - · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction - · in-stent restenosis · post-delivery expansion of balloon expandable coronary stents

The Sapphire NC Plus coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The non-compliant balloons, available in diameters from 2.0- 5.0mm and lengths from 8-18mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F (6F for Ø4.5-5.0mm) or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to 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. This Special 510(k) describes the addition of the Ø4.5- 5.0mm balloon configurations to the Sapphire NC Plus PTCA catheter family.

The Teleport microcatheters are indicated for: supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature. exchanging guidewires in the coronary and peripheral vasculature. the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

The Teleport family of microcatheters are single lumen catheters, offered in two shaft sizes (2.0F and 2.1F) with working lengths of 135cm or 150cm, designed for use in the coronary, peripheral, and abdominal vasculature. The shaft profiles gradually decrease from 2.6F (0.034") to 2.0F (0.0265") for the 2.0F configuration (Teleport), and 2.7F (0.036") to 2.1F (0.0275") for the 2.1F configuration (Teleport Control) respectively. The catheter consists of four sections: body shaft, proximal tip shaft, distal tip shaft, and a radiopaque tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purposes of improving myocardial perfusion. The Sapphire® II PRO balloon dilatation catheter (1.5-4.0mm configurations) is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. The Sapphire® II PRO balloon dilatation catheter is also indicated for: percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO balloon dilatation catheter is a rapid exchange balloon catheter with a working length of 140cm design for both coronary and peripheral indications. This catheter was previously cleared for coronary use (K173680, K163114) and this submission is intended to support the peripheral use of this balloon catheter. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-4.0mm and lengths from 5-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for the Ø1.0-1.5mm configurations). The catheter is compatible with 4F or larger guiding sheaths or 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a guiding sheath or guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The Sapphire II PRO coronary dilatation catheter (1.0-1.25mm configurations) is indicated for: * balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (>70% stenosis) for the purposes of improving myocardial perfusion.

The Ø1.0-1.25mm Sapphire II PRO coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.0-1.25mm and lengths from 5-15mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. One radiopaque platinum marker band is centrally located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to 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 Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a rapid exchange balloon catheter for peripheral indications with a working length of 150cm. The minimally compliant balloons, available in diameters from 1.5-6.0mm and lengths from 15-120mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. The balloon material is made of a minimally compliant material with a rated burst pressure of 20 atm (Ø1.5-4.0mm) or 18atm (Ø4.5-6.0mm). Hydrophilic lubricious coatings are applied to the distal section of the catheter. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon tube which is internally supported by a stainless steel hypotube. Two radiopaque platinum/iridium marker bands are located within the balloon shoulders. The internal lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the RX port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 3mm in length located on the proximal shaft specifically designed to be highly visible, indicate catheter position relative to the guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.