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ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire devices are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the site of filter basket placement should be from 3mm to 7.5mm.

Both the subject and predicate ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices consists of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (overthe-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. The ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices have a filter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

Cordis Angiographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

The SUPER TORQUE® MB Angiographic Catheter is a thin plastic tube which is inserted into an artery through a small incision in the skin. The catheter is guided to the area being examined, and contrast material is injected through the tube and images are captured using a small dose of ionizing radiation (x-rays). Each SUPER TORQUE® MB Angiographic Catheter consists of a braided Polyurethane body and a non-braided Polyurethane tip section having multiple, radiopaque marker bands.

SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, poplited, infra poplited and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and selfexpanding stents in the peripheral vasculature.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which is the same device as its predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333), with an additional indication. The device has identical technological characteristics as the predicate, SABER™ .035 PTA Dilatation Catheter (K201333). SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI). The SABER™ .035" PTA Dilatation Catheter has identical device/component constructions as the predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). Same as the predicate, the balloon of the SABER™ .035 PTA Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement when under fluoroscopy. The SABER™ .035 PTA Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a quide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.

BRITE TIP RADIANZ™ Guiding Sheath is intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.

Each BRITE TIP RADIANZ™ device consists of a 6F compatible guiding sheath, a vessel dilator (0.035" guidewire compatible) and a removable hemostasis valve. The guiding sheath has a lubricious hydrophilic coating to enhance entry and withdrawal during vessel access, and a low-profile outer diameter with a smooth transition to the vessel dilator to minimize or prevent radial vasculature trauma and spasm of the radial artery. The sheath is available in two lengths, 110 cm and 135 cm. The sheath hub is an over-molded hub with a luer and is compatible with the removable hemostasis valve provided (described below) and with other hemostasis valves or common vascular accessories of the user's choice. The vessel dilator is compatible with 0.035" guidewires (not included) and is tapered such that it creates a smooth transition between the guiding sheath tip and the guidewire. The vessel dilator hub is over molded and includes a locking feature located in the distal end of the hub to facilitate locking the vessel dilator to the sheath cannula proximal hemostasis valve. The system contains a removable hemostasis valve to facilitate entry and withdrawal of intravascular devices through the guiding sheath and minimize the backflow of blood. It also has a side-port arm with attached 3-way stopcock for flushing or aspiration. The preassembled hub connector is removable, such that it can be exchanged for a hemostasis valve or other common vascular accessory of the user's preference.

The SABERX RADIANZ™ PTA Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infra poplited and renal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a single-use sterile device, sterilized by ethylene oxide. The SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (hereafter referred to as "SABERX RADIANZ™") is a Rapid Exchange design, consisting of a single inflation lumen and a distal quidewire lumen. The quidewire lumen permits the use of a quidewire (0.018 in.) to facilitate advancement of the catheter to and through the stenosis to be dilated. It begins at the distal tip and terminates at the guidewire exit port. The guidewire exit-port (hole) is 40 cm from the distal tip. The proximal hub section of the catheter provides a clear, onepiece hub with a single-luer port for inflation of the balloon. The coaxial, concentric dual lumen distal shaft connects proximally at the quidewire exit port and distally to the balloon. The proximal shaft with a supporting stainless-steel core wire connects proximally to the hub and distally to the guidewire exit port. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. A balloon protector is placed over the balloon to maintain a low profile. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. A lubricious hydrophilic coating covers the distal tip. balloon, and a portion of the shaft, to facilitate balloon placement. The SABERX RADIANZ™ catheter will have multiple radiopaque marker bands that provide fluoroscopic visual reference points to facilitate balloon positioning within the vessel. The SABERX RADIANZ™ catheter is compatible with standard 0.018" guidewires and 4F, 5F, or 6F catheter sheath introducers. The usable catheter length is 190 cm and the proximal shaft has two exit markers located at 115 cm and 140 cm from the distal tip. The SABERX RADIANZ™ catheter is available in eighty-two (82) product configurations with balloon diameters of 2.00 - 8.00 mm in 0.50 mm or 1.00 mm increments. The working lengths of the treatment balloon will be offered in lengths from 20 mm to 300 mm. The associated accessories for SABERX RADIANZ™ include: - . Flushing Needle.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which shares the similar technological characteristics as the predicate, Powerflex Pro PTA Catheter. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI). The SABER™ .035" Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has similar device/component constructions as the predicate. Powerflex Pro PTA Catheter. Same as the predicate, the balloon of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement, when under fluoroscopy. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a guide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon. The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.

RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery.

RAIN Sheath™ Transradial is indicated to facilitate placing a catheter through the skin into a radial artery. Each RAIN Sheath™ device consists of a sheath introducer, a vessel dilator (0.021" guidewire compatible), an IV cannula needle and/or a bare access needle, and a 45 cm 0.021" guidewire (either bare or hydrophilic). The device configurations with the hydrophilic guidewire contain only the IV cannula needle whereas device configurations with the bare wire contain only the bare needle. The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel dilator from backing out of the cannula. RAIN Sheath™ device is available in sixteen (16) product configurations which differ based on French size and length, and the specific wire and needle included in the system, as indicated in the table below. It is offered in French sizes of 4F, 5F, 6F and 7F, with lengths of 10 cm and 16 cm. RAIN Sheath™ device is a single-use sterile device, sterilized by ethylene oxide.

The RAILWAY™ Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices.

The RAILWAY™ Sheathless Access System (hereafter referred to as "RAILWAY System" or "RAILWAY") facilitates the direct radial access of separately sold Cordis quiding catheters. Each RAILWAY System consists of two 136 cm nylon vessel dilators (0.021" and 0.035" quidewire compatible), a 20 Gauge IV cannula needle and/or a 21 Gauge stainless steel access needle, and a 45 cm 0.021" mini-guidewire (either stainless steel or hydrophilic coated Nitinol). The system configurations containing the hydrophilic guidewire do not contain a bare needle. The RAILWAY System has been dimensionally optimized for use with Cordis quiding catheters. The compatible guiding catheters and 0.035" guidewire are not included in the system. The RAILWAY dilators have a tapered tip and a lubricious hydrophilic coating on the distal 20 cm section to facilitate access and ease of insertion. The geometry of the RAILWAY dilator taper and outer diameter (OD) have been optimized to provide atraumatic transitions between the dilator and a quiding catheter and between the dilator and quidewire. The dilator compatible with a 0.021" quidewire is intended for use in combination with a compatible guiding catheter to initiate sheathless (i.e. without a catheter sheath introducer) radial vascular access via insertion over a guidewire into the skin, subcutaneous tissue, and artery. After access is achieved, using either RAILWAY or a traditional catheter sheath introducer, the 0.035" RAILWAY dilator can be used to support the tracking of a compatible guiding catheter over a guidewire up to but not beyond the subclavian artery. RAILWAY is available in ten (10) product configurations which differ on the basis of guiding catheter compatibility (catheter brand and French size) and the specific wire and needle(s) included in the system, as indicated in the table below. The dilators are color coded by size to align with accepted conventions for the guiding catheters to which the dilators are compatible. The RAILWAY System is a single-use sterile device, sterilized by ethylene oxide. The RAILWAY System is compatible with 5F, 6F and 7F guiding catheters of 90 cm and 100 cm lengths. The dilators have been optimized for fit with either the Cordis VISTA BRITE TIP® or Cordis ADROIT® guiding catheters and have not been dimensionally optimized for compatibility with other guiding catheters. The appropriate RAILWAY dilator must be chosen to match the guidewire and guiding catheter sizes selected for the procedure. The RAILWAY System is for professional use in a hospital, catheterization laboratory, or other suitable healthcare facility only.

The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion. The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating on the distal 40 cm of the catheter body. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

The OUTBACK Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.

The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.