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The VIABIL® Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures. The GORE VIABIL® Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.

The VIABIL® Biliary Endoprosthesis is a flexible, self-expanding stent with an inner tubular lining that is radially compressed and secured to the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL® Biliary Endoprosthesis at the target site in the biliary tract. There are two principle components of the device: the endoprosthesis and the delivery catheter. The endoprosthesis is available in two diameters (8 mm and 10 mm), four lengths (4 cm, 6 cm, 8 cm, and 10 cm), and is available both with and without transmural drainage holes. Two catheter lengths are available: a 40 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 200-cm working length catheter for endoscopic delivery.

The Hier-Spec vaginal speculum is a non-metal (Acrylic and Polycarbonate), hand held device used to open the vagina and provide access to the cervix for gynecological or obstetrical examinations and procedures.

When the device is in the closed position, for insertion into the vagina, the bow arms are in a horizontal position and the handles are open to approximately 45 degrees. After the device is inserted into the vagina, the handles are squeezed together and the connecting rail rotates the bow arms into a horizontal position to open the vaginal canal.

No new claims or indications are made.

The proposed kit raises no new issues of safety or efficacy. In incorporating the components into a kit no modifications have been made which will affect safety or efficacy. Sterilization method and packaging are essentially the same. The I.V. sets and transducer protectors are legally marketed as individual components. The arterial and venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial and venous bloodlines have been tested for biocompatibility and data provided. The integrity of the bonded connections of the bloodlines and of the connection of the transducer protectors to the monitor lines have been tested and data provided.