Search Results
Found 1 results
510(k) Data Aggregation
(245 days)
The Disposable Ureteral Stents 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 are placed using endoscopic technique. The indwelling time should not exceed 30 days.
The Disposable Ureteral Stents 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 radiopaque polycarbonate-based polyurethane with hydrophilic coating. The subject stents include two stent types: Type C and Type D stents. The only difference between the two types of stents is the opening at the stent end (Type C - single opening at one end only vs. Type D - double openings with one at each end).
The Disposable Ureteral Stents are available in 4.0 to 8.0 French (Fr) diameter, with lengths ranging from 14.0 to 28.0 centimeters (cm) (4Fr × 14 cm for pediatric patients and other sizes for adults). The stents are supplied sterile, packaged with a small pusher tube. Depending on configurations, the device package may include an optional guide wire, clamp or silk thread in addition to the stent and pusher tube.
The Disposable Ureteral Stents are not intended for long-term use. The stents are labeled for indwell time not to exceed thirty (30) days and no repeated use. The Silk thread should be removed after 14 days.
N/A
Ask a specific question about this device
Page 1 of 1