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The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

The Beacon® Tip Torcon NB® Advantage Catheters are visually identified by a distal radiopaque tip bonded onto a nylon catheter shaft with braided stainless steel. Beacon® Tip Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, and 6.0 French with lengths measuring 40 to 170 centimeters. The catheter inner lumen is manufactured to accept a 0.035 or 0.038 inch diameter wire guide. These devices are manufactured without sideports and in a variety of distal tip configurations. The Torcon NB® Advantage Catheters are selective angiographic catheters manufactured with a thinwall radiopaque nylon material and constructed with stainless steel braiding. The Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, 6.0, 7.0 and 8.0 French with lengths measuring 35 to 150 centimeters. The catheter inner lumen is manufactured to accept a 0.025, 0.035, or 0.038 inch diameter wire guide. These devices are manufactured with zero to twelve sideports, depending on the distal curve radius, and are available in a variety of distal tip configurations. These tips may be tapered at the distal endhole, depending upon device specifications. The catheters are also available in a variety of distal tip configurations. Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are for use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

The Advance® Salivary Balloon Catheter is intended for the dilation of lesions and strictures in the submandibular and parotid salivary ducts.

The Advance® Salivary Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5. 2.0, 2.5 and 3.0 millimeters in a balloon length of 2 centimeters. The catheter is available in an outer diameter of 2.5 French and in a length of 30 centimeters. Hydrophilic coating is applied to the distal 15 centimeters of the catheter shaft, which provides a lubricious surface when wetted. The balloon catheter is supplied with a 0.014 inch (0.36 millimeter) diameter stainless steel mandrel wire guide in a length of 50 centimeters. It is sterile and intended for one-time use.

The Flexor® Radial Hydrophilic Introducer Access Set is introduce diagnostic and interventional devices in radial arterv access procedures.

The Flexor Radial Hydrophilic Introducer Access Set is comprised of an introducer sheath, a dilator, a wire guide, and an access needle.

The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. The Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

The Cook Ciaglia percutaneous tracheostomy devices are designed for percutaneous dilational tracheostomy for management of the airway. More specifically, the devices allow for two approaches to the dilation of the stoma: serial dilation (Ciaglia Percutaneous Tracheostomy Introducer Set) or single-stage dilation (Blue Rhino® and Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set). Serial dilation is achieved using numerous progressively larger dilators. Single-stage dilation is achieved with a single rhino-horn-shaped dilator using an in-and-out motion. The Cook Ciaglia percutaneous tracheostomy devices are sold sterile for single use. There are multiple configurations that include various set and tray components (Table 1) associated with the procedure and/or in gaining percutaneous access.

The Cantata® 2.9 Microcatheters are intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

The Cantata 2.9 Microcatheters are braided microcatheters with hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. The devices include one radiopaque marker band to assist in fluoroscopic visualization of the catheter during use. The catheters are available in 2.9 French shafts and are available in 100, 110, 135, and 150 centimeter lengths. The devices are compatible with a 0.038 inch (0.97 millimeters) diameter angiographic catheter and can accept 0.018 inch (0.46 millimeters) and 0.021 inch (0.53 millimeters) diameter wire guides.

The Advance CS Coronary Sinus Infusion Catheter is intended for temporary occlusion of the coronary sinus for infusion of contrast media, drugs, or therapeutic agents; or possible introduction of devices into the coronary venous system.

The Advance® CS Coronary Sinus Infusion Catheter is an over-the-wire catheter. The 5.0 Fr balloon catheter is compatible with a 0.035 inch diameter wire guide. The device will be supplied sterile and intended for one-time use.

Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject® PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The proposed Spectrum Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr and 5.0 Fr single and double lumen catheters. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

The Advance® 35LP Low Profile PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapoplal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Advance® 35LP PTA Balloon Dilatation Catheters are over-the-wire catheters that will be available with inflated balloon diameters of 3, 4. 5, 6, 7, 8, 9, 10, and 12 millimeters and balloon lengths of 1.5. 2. 2.5. 3. 4. 6. 8. 10. 12. 14. 17. and 20 centimeters. The catheters are 5.2 French or 5.7 French, dependent upon device specification, and will be available in lengths of 80 and 135 centimeters. The catheters are compatible with a 0.035 inch (0.89 millimeter) diameter wire guide. The catheters will be supplied sterile and are intended for one-time use.

The Entuit™ Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. The Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

The Entuit™ Secure Gastrointestinal Suture Anchor Set and the Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Set consist of 2 or 3 introducer needles with pre-loaded suture anchors and a wire guide. A notch is located on the distal tip of the introducer needle. The coil anchor is placed in the notch prior to placement. The proximal end of the suture anchor contains the suture retention mechanism. The retention mechanism of the Entuit Secure Gastrointestinal Suture Anchor consists of an extension spring which is glued on the proximal end within a suture retention housing. The suture is threaded through the coils of the extension spring. When the suture retention mechanism is pushed towards the anchor, tension is applied to the spring, which causes the coils of the spring to open. This allows the suture to slide through the spring and allows the retention mechanism to slide along the suture. When the retention mechanism is pulled away from the anchor, the coils of the spring compress and clamp down on the suture. This does not allow the suture to slide through the spring and maintains tension on the suture anchor. The adjustable suture retention mechanism of the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set consists of a suture retention housing, a compression spring, a compression jaw, and a removable adjustable tab. The suture is threaded through the suture retention housing and held in place by the compression jaws and the compression spring. The adjustable tab must be compressed for the suture to be adjusted. When the adjustable tab is compressed, the spring and compression jaws do not contact the suture. This allows the suture retention mechanism to slide along the suture. Once the suture retention mechanism is in place, the compression jaws will maintain tension on the suture anchor, and the adjustable tab can be removed. Both of the proposed devices are supplied sterile and are intended for one-time use.

The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

The Cook® Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction at term when the cervix is unfavorable for induction. The tip of the Cook® Cervical Ripening Balloon is placed through the vagina and the cervical canal into the uterus. The distal balloon is positioned against the internal cervical os and inflated with up to 80 mL of saline; the proximal balloon is positioned against the external cervical os and also inflated with up to 80 mL of saline. The Cook Cervical Ripening Balloon provides gradual mechanical cervical dilation by simultaneously providing pressure on the internal and external cervical os. In addition to the standard version, the Cook® Cervical Ripening Balloon is also available with a removable stylet to add rigidity to the catheter and aid in placement of the balloon through the cervix. The stylet runs the length of the catheter shaft of the Cook® Cervical Ripening Balloon in a separate lumen that is closed at the distal tip. The user removes the stylet from the device once the distal uterine balloon is above the level of the internal cervical os.