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The Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The PALMAZ BLUE Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis SLALOM 0.18" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz BLUE .018 Transhepatic Biliary Stent System) to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and subsequently the delivery system is removed. The Cordis PALMAZ BLUE .018 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries. The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence. The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline. Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature: Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.

The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System is a balloon-expandable, stainless steel stent that is provided premounted upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed for expansion to diameters from 3 to 6 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile and is intended for single use only.