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Ureteral Stents (AF-D series) are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral Stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques. The indwelling time should not exceed 30 days.

Ureteral Stents (AF-D series) are a set of ureteral stents used for temporary internal drainage from the ureteropelvic junction to the bladder. The subject ureteral stent is a flexible, tubular double pigtail stent composed of thermoplastic polyurethane with hydrophilic coating. Depending on configurations, the device may include a ureteral stent only, or a stent with an introducer and a clamp, or a stent with an introducer, a guidewire and a clamp. Ureteral Stents are available in 4.0 to 7.0 French (Fr) diameter, with lengths ranging from 8.0 to 28.0 centimeters (cm). The device is supplied sterile, intended for single use only, and is available for prescription use only. Ureteral Stents are not intended as a permanent indwelling device. The subject stent is labeled for indwell time not to exceed thirty (30) days only.

The Disposable ureteral stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent should be placed using endoscopic surgical technique. The stent is not intended as a permanent indwelling device. The indwelling time should not exceed thirty (30) days. The 4Fr model is intended to be used for pediatric (adolescents, children, and infants) patients.

Disposable ureteral stents are sterile, single-use devices, that are inserted into the ureter endoscopically to facilitate the drainage of urine from the kidney to the bladder and can be used for treatment of ureter blockage and stricture. The stents are available in 4.0 to 12.0 French (Fr) diameter, with lengths ranging from 12.0 to 30.0 centimeters (cm). The device includes a polyurethane stent, a push catheter, and optional accessories - a guide wire (coated guide wire, hydrophilic guide wire, or zebra guide wire) and a guide wire sheath. The stents include Type A, C, D, F, and H stents all of which are composed of tube bodies only. The stents are secured in the urinary tract with pigtail loops on the proximal (renal pelvis) and distal (bladder) ends. The Disposable ureteral stents are not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days only.

The Ureteral Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician. The Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.

The Ureteral Stents are sterile, single use, disposable devices that provide a lumen that allows fluids to move from the kidney to the bladder. The Ureteral Stents are provided in multiple French sizes and lengths. The Urinary Diversion Stent Sets are sterile, single use, disposable devices that allow internal drainage from the kidney to an external collection system.

The RELIEF™ Ureteral Stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques. The stent is not intended as a permanent indwelling time should not exceed thirty (30) days.

The RELIEF™ Ureteral Stents are sterile, single-use devices. The stents are available in 6Fr, with lengths of 24 cm and 26 cm. The ureteral stent is constructed of a radiopaque polymer tube with a central lumen with side holes positioned along its length to provide drainage of urine from the kidney to the bladder and includes hydrophilic coating. Along the stent are printed insertion markers throughout its length. The stent includes a radiopaque soft polymeric proximal tubular coil and body segment attached to a 4 cm tether of suture material that is placed along the ureter intramural segment, allowing natural opening, and closing of the ureteral orifice, thereby preventing vesicoureteral reflux. The tether is attached to a radiopaque distal bladder coil constructed of a monofilament (non-lumened), polymeric segment, allowing it to float in the bladder, thus precluding any tension on the tether or coil. The RELIEF™ Ureteral Stent package contents consist of: RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm - . RELIEF™ Ureteral Stent - Stent pusher tube with radiopaque tip - . Pigtail straightener The RELIEF™ Ureteral Stent is not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days.

To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection. The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, seromas, urinomas, or any loculated fluid collection.

All Purpose Drainage catheters are designed to provide constant, unobstructed fluid drainage from various fluid accumulations to an external and/or internal collection sites and to ensure stability during treatment. These ends are met through the choice of drainage material and by incorporating a secure fixation method in the drainage site (internally by pig-tail or "J" style tips and externally, by means of suture or adhesive). Percutaneous placement is accomplished with radiological guidance. Select Boston Scientific All Purpose Drainage catheters are coated with a hydrophilic material, Glidex™ , for the reduction of surface friction during placement. Some of these catheters are also available with a biocompatible, distal tip (Temp-Tip™). The tip's internal diameter allows the guidewire to direct the tip for accurate catheter placement; however, soon after placement, the Temp-Tip™ material dissolves, allowing the full diameter of the catheter lumen to contribute to site drainage. All Purpose Drainage catheters are manufactured with one of two types of resins, Flexima or Percuflex. - Flexima is a biocompatible polyurethane (Tecoflex) known for its flexibility, strength, and kink resistance. Flexima comes in durometers ranging in Firm, Regular and Soft and uses a radiopacifier for visualization under fluoroscopy. - Percuflex is an ELVAX™ 460, ethylene vinyl acetate (EVA) copolymer for patient comfort. This material is available in firm (white in color) and regular (blue in color) durometers. The firmer durometers provide more pushability during device placement. A radiopaque additive, bismuth subcarbonate, incorporated throughout the catheter tube also aids radiopacity and percutaneous placement.

Silicone double loop ureteral stents: The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months. Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis: For Pyelostent® Silicone double loop ureteral stents: Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients. For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients. The Pyelostent® and Stenostent® Silicone double loop ureteral stents may remain implanted for up to 12 months.

The ImaJin Silicone double loop ureteral stent kit product family was originally cleared as Porges™ Silicone Double Loop Ureteral Stents in 510(k) K013921. The ImaJin Silicone double loop ureteral stent family consists of three single use, autostatic stents intended to drain the upper urinary tract and allow healing in case of ureteral obstacles or damage to the ureter. The Pyelostent and Stenostent Silicone double loop ureteral stents have partial and complete reinforcement along the straight catheter section respectively to add crush resistance. The devices are provided with a pusher and in some cases a guidewire. The Silicone double loop ureteral stents are ethylene oxide sterilized, single use, implantable devices. The current submission is to update the indication for use statement, revise the Instructions for Use, add information on MRI compatibility, modify drainage hole size in some models, modify packaging, and modify the device performance specifications.

The RELIEF™ Ureteral Stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture. malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. The stent is not intended as a permanent indwelling time should not exceed thirty (30) days.

The RELIEF™ Ureteral Stents are sterile, single-use devices. The stents are available in 6Fr, with lengths of 24cm and 26cm. The ureteral stent is constructed of a radiopaque polymer tube with a central lumen with side holes positioned along its length to provide drainage of urine from the kidney to the bladder and includes hydrophilic coating. Along the stent are printed insertion markers throughout its length. The stent includes a radiopaque soft polymeric proximal tubular coil and body segment attached to a 4 cm tether of suture material that is placed along the ureter intramural segment, allowing natural opening, and closing of the ureteral orifice. The tether is attached to a radiopaque distal bladder coil constructed of a monofilament (non-lumened), polymeric segment, allowing it to float in the bladder, thus precluding any tension on the tether or coil. The RELIEF™ Ureteral Stent package contents consist of: RELIEF™ Ureteral Stent, Stent pusher tube with radiopaque tip, Pigtail straightener. The RELIEF™ Ureteral Stent is not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days only). The following models are available for the subject device: RS-001: 6Fr x 24cm, RS-002: 6Fr x 26cm.

The NovoFlow Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.

NovoFlow Reinforced Ureteral Stents are implantable ureteral stents used to maintain urine drainage and allow healing of the ureter. They are inserted into the ureter during a surgical procedure using mainly a retrograde technique, although an antegrade approach is also possible. The stents are supplied in 7 Fr or 8 Fr diameters and lengths from 26 cm through 30 cm, with both tips open (O/O). NovoFlow Reinforced Ureteral Stents are supplied in kits which contain the following components: - A double loop ureteral stent - A steerable pusher, packed separately Also contained in some kits: - -An Orchestra® Hydrophilic guidewire, packed separately The NovoFlow Reinforced Ureteral Stents and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.

The JFil® Ureteral Stents are used for temporary internal drainage of the ureteropelvic junction. The stents may be placed using endoscopic techniques. The stents are not intended as permanent indwelling devices, it is recommended that the indwelling time does not exceed 14 days. Target population: adults only (greater than 21 years of age).

The JFil® Ureteral Stents consist of a tube-like device that is inserted into the ureter to allow the passage of the urine in the treatment of ureteral injuries and ureteral obstructions. This polyurethane stent has a single loop on the proximal tip and a polypropylene-monofilament surgical thread on the distal tip. JFil stents are 6.0 or 7.0 French (Fr) in diameter and 8 or 16 cm in specified length. The stent is provided with a 63 cm length pusher and may include a Nitinol Guidewire in the kit. The pusher consists of a radio-opaque ring connected to a tubing, and is intended to allow pushing, placing, and releasing the stent inside the patient. This stents can only be used by trained professionals in a clinic or hospitals environment. The JFil Ureteral Stents are sterile and for single use only. The stents are also available in ECO-kits which do not include a guidewire. The stents can be removed cystoscopically by gently pulling on the surgical thread.

Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit: The Ureteral Stent is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not externally. Percuflex™ Nephroureteral Stent System: The Percuflex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent. Amplatz Anchor™ Catheter System: The Amplatz Anchor™ Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.

The Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit is designed with the classic pigtail shape on each end and is intended to facilitate drainage internally from the renal pelvis to the bladder and stenting of the ureter without external access after placement. The ureteral stent systems contain a suture to adjust the pigtail shape or to remove the stent. These devices are constructed of a proprietary, biocompatible copolymer called Percuflex™ for patient comfort with a radiopaque resin throughout the catheter tube. Designated Percuflex™ Ureteral Stent Systems are also available with a proprietary Glidex™ hydrophilic material for the reduction of surface friction during placement or with a dissolving distal tip (Temp-Tip™). The dissolving tip internal diameter aids in placement, then dissolves soon after placement to allow a larger lumen for drainage. The Percuflex™ Nephroureteral Stent System is also designed with the classic pigtail shape on each end and facilitates drainage from the internal ureteropelvic junction to the bladder with external access to the stent. The Nephroureteral Stent System also incorporates the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. Select models are available with a Temp-Tip™ which dissolves soon after placement. A suture is locked in place with a stopcock to retain the pigtail shape. A luer allows for connection to other drainage devices with a conical fitting. The Amplatz Anchor™ Catheter System is designed with a unique locking Malecot diamond shape to facilitate percutaneous nephrostomy, abscess or external biliary drainage. The Amplatz Anchor™ Catheter Systems also incorporate the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. A suture is locked in place with a stopcock to retain the 2-winq design. A luer allows for connection to other drainage devices with a conical fitting. These Percuflex™ Drainage Catheters and Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. Where long-term use is indicated, it is recommended not to exceed 90 days of indwelling time.