Search Results

It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing access for endoscopes and surgical instruments.

The product consists of a needle tube, a needle hub, a rear end, equipment channel interface E, fiber image channel interface F, irrigation channel interface I, an obturator, a needle-free joint and a two-way water valve, and that primary package of the product contains a protective sleeve which is only used for product protection. The product is sterilized by ethylene oxide and is single use.

For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.

The Kolibri® Percutaneous Nephrostomy Catheters are available in two configurations based on the tip configuration termed either J or Malecot. The distal end of the J catheter resembles a loop, and the distal end of the Malecot catheter has 4-wings which form an open basket to hold the catheter in place. J and Malecot catheters are single lumen catheters with outer diameters ranging from 6 Fr to 20 Fr. The J and Malecot catheters are manufactured from the material branded Vortek by Coloplast. The catheters are supplied either individually or as part of a kit. The following components are included depending on the specific configuration: - · Stylet - · Silicone sleeve - · Stopcock - Female Luer - Urine bag connector - Guidewire (kits only) - · Dilator set(s) (kits only) - · Chiba needles (kits only) The dilators. Chiba Needles, and quidewires are all packaged separately. The J and Malecot catheters are supplied sterile via ethylene oxide for single use. Kolibri Direct Puncture Set The Direct Puncture Set consists of an 8 Fr or 10 Fr J catheter with a silicone sleeve, stopcock, urine bag connector, transparent reinforced tube, stainless-steel trocar needle, and stainlesssteel stylet. The Direct Puncture Set is supplied sterile via ethylene oxide for single use.

The In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the percutaneous tract dilation). The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).

The In-Ka® Percutaneous Balloon Dilatation Catheters are balloon catheters intended for dilation of the nephrostomy tract to create a percutaneous renal access. The catheter is a 7 Fr double lumen catheter supplied with a radiopaque Amplatz sheath. The catheter is supplied with or without an inflation device (manometer) depending on the model. Amplatz sheaths are also sold separately from the catheter. The 30 Fr balloon is equipped with a radiopaque stainless-steel ring on its distal extremity corresponding to the balloon's working length to allow radiographic visualization and positioning. Each In-Ka catheter is supplied sterile for a single use.

Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage. Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage. Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.

The bundled submission includes the Cook-Cope Loop Nephrostomy Set, Ultrathane® Nephrostomy Set with Mac-Loc®, and the Ultrathane® Suprapubic Set with Mac-Loc® - . Cook-Cope Loop Nephrostomy Set and Catheter: The catheter is placed using standard percutaneous nephrostomy techniques into the kidney. The catheter is then secured in place by pulling the suture taut to create the distal retention loop, wrapping around the catheter shaft and knotting the suture. The latex is then folded over the suture and the excess suture is cut off. The catheter is kept in place within the patient using a retention disc. - . Ultrathane Nephrostomy Set with Mac-Loc: The catheter is placed using standard percutaneous nephrostomy techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the monofilament, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using a retention disc. - Ultrathane Suprapubic Set with Mac-Loc: The catheter is placed using standard . suprapubic techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the tether, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using the enclosed StatLock device. The subject percutaneous drainage catheter sets consist of a flexible tube with an open distal tip and drainage holes. The distal end of the subject devices has either a Mac-Loc locking loop or a cope loop. A Mac-Loc locking loop mechanism secures the distal catheter loop configuration by means of a nylon monofilament. After the catheter is placed in the desired location, the nylon thread is pulled tight to form the distal loop configuration. Then the locking cam lever can be pushed down to snap into position, thereby locking the distal loop in position. The cope loop configuration is formed by pulling back the suture, and then the loop can be locked in place by sliding a latex sleeve over the suture. Some catheter sets have a radiopaque marker to aid the user in placement. The proximal hub assembly of the devices provides a Luer lock hub to allow the user to connect to a fluid collection device (not subject of this submission). Accessories include introducing catheters, catheter securing devices, needles, cannulas, stylets, dilators, and wire guides.

Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system for patients aged 12 years and older.

The Lawson Retrograde Nephrostomy Wire Puncture Set is used to gain percutaneous access to the kidney by means of a controlled fine wire puncture from within the collecting system. The Lawson Retrograde Nephrostomy Wire Puncture Set is composed of the tipdeflecting wire guide, catheter, sheathed puncture wire, coaxial needle assembly (inner and outer needle cannulae) and working wire guide. The tip-deflecting wire guide is used to direct the catheter into the desired calyx in a retrograde manner using standard access techniques, followed by exchange of the deflecting wire with the sheathed puncture wire. To initiate percutaneous nephrostomy access, the puncture wire is unsheathed and advanced from the catheter through the kidney towards the patient's flank and through the skin. The coaxial needle assembly is then advanced over the puncture wire and into the renal collecting system, and then the puncture wire and inner needle cannula are removed to allow a working wire guide to be placed through the outer needle cannula. - . The tip-deflecting wire guide has a three-ring handle which twist-locks with the catheter. The tip-deflecting wire guide is made from stainless steel and is available in an outer diameter of 0.045 in. - . The catheter is available in an outer diameter of 7 Fr with a length of 82.5 cm and made of braided nylon tubing. The sheathed puncture wire can interlock with the proximal portion of the catheter. - The sheath is made of radiopaque TFE tubing which extends 1 cm from the . catheter when locked together. The sheath is available in an outer diameter of 3 Fr with a length of 85 cm. - . The puncture wire is made of stainless steel with a plastic pin vise handle. The puncture wire has an outer diameter of 0.43 mm with a length of 145 cm. - . The needle set has a 22 gage inner needle that is 22.5 cm in length with the outer needle being 18 gage and 14 cm in length. - . The working wire guide is made of stainless steel and is 0.97 mm in diameter and 145 cm in length. The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures. The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.

The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube and syringe. The balloon catheter can be sold separately with the stylet and syringe. The radiopaque balloon catheter has an outer diameter of 14.0 French and a tip diameter of 17.0 French, with a working length of 25 centimeters. The clear polyethylene balloon measures 15 centimeters in length and has an inflated diameter of 12 millimeters. The flexible stylet is 8.5 French and is manufactured from polyurethane material. The flexible stylet, designed to be inserted through the proximal end of the balloon catheter, extends 2 millimeters from the balloon catheter tip when assembled. The stent is manufactured from radiopaque polyurethane with an outer diameter of 5.0 French and a length of 75 centimeters. The stent is designed with two adjustable and removable adapters located at the proximal end of the stent. The Y-connecting tube is made of non-radiopaque polyvinylchloride material with an outer diameter of 14.0 French, and a length of 30 centimeters. A 10 mL Luerlock syringe is also provided in the set and is used to inflate the balloon through the inflation check valve. The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is supplied sterile in a Tyvek peel open pouch and labeled with a three-year shelf life. The subject device has a maximum indwell time of 96 hours (4 days) for the stent and 48 hours (2 days) for the balloon catheter and is labeled as a single-use device.

Used to establish a percutaneous tract into the renal pelvis for catheter placement or stone manipulation. Used under fluoroscopy or ultrasound for initial location and positioning within the renal collecting system during a percutaneous nephrostomy.

The Percutaneous Entry Set is comprised of a Skinny Needle® with Chiba Tip, a Disposable Two-Part Trocar Needle, 8 dilators and a wire guide. The Skinny Needle® is comprised of a stainless steel stylet inserted through a hubbed stainless steel cannula. The cannula has gauge size of 22 with a length of 20 centimeters. The distal end of the cannula is a Chiba tip, beveled at a 30° angle. The Disposable Two-Part Trocar Needle is comprised of a stainless steel beveled stylet which can be inserted through a hubbed stainless steel cannula. The cannula comes in a gauge of 18 with lengths in 15 and 20 centimeters. When the beveled stylet is inserted through the cannula, the length from the distal endpoint of the cannula to the proximal starting point of the bevel on the wire is 0-2 millimeters. Needles have an optional Echotip® design, consisting of a series of very small dimples on the surface of the needle tip that enables it to be visible under ultrasound. The dilators are manufactured from polyethylene tubing in 6.0, 7.0, 8.0, 9.0, 10.0, 12.0, 14.0 and 16.0 French sizes. All dilators measure 20 centimeters in length and have 8 to 15 millimeter taper with a 0.040 inch diameter thru hole. The wire guide is characterized by a heavy-duty shaft, with a gradual transition to a very flexible distal tip. This wire guide type is manufactured in a 0.038 inch diameter, and measures 80 centimeters in length with a 3 millimeter Safe-T-J tip. This wire guide is constructed of a polytetrafluoroethylene coated stainless steel. The Percutaneous Entry Set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a 3-year shelf life. The Skinny Needle® with Chiba Tip is also available for sale individually. The Skinny Needle® with Chiba Tip will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a 3-year shelf life. The Disposable Two-Part Trocar Needle is also available for sale individually. The Disposable Two-Part Trocar Needle will be supplied sterile and is intended for onetime use. The set is packaged in a peel-open pouch with a 3-year shelf life.

Percutaneous Neonatal Pigtail Nephrostomy Set: This device is intended for percutaneous placement of a pigtail catheter in the renal pelvis for nephrostomy drainage in neonatal patients. Pediatric Nephrostomy Stent Set: This device is used as a nephrostomy drainage catheter and ureteral stent in pediatric patients 2 years and older.

The Percutaneous Neonatal Pigtail Nephrostomy Set comprises a 6.0 French (Fr) pigtail drainage catheter, a 22-gauge trocar needle, an 18-gauge trocar needle, a 5.0-Fr dilator, a 6.0-Fr dilator, a 7.0-Fr dilator, a retention disc and pull tie, a 10-Fr connecting tube, and a 0.038-inch (in) diameter, 30-centimeter (cm) wire guide. The Pediatric Nephrostomy Stent Set comprises an 8.2-Fr pigtail drainage catheter with 4.7-Fr stent tubing, a retention disc and pull tie, and 10-Fr connecting tube.

The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

The Ultraxx™ Nephrostomy Balloon Catheter is a double-lumen catheter indicated for a nephrostomy procedure by dilating the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The device is intended for limited duration use, not to exceed 24 hours in the body. The Ultraxx Nephrostomy Balloon Catheter Set is comprised of the Ultraxx balloon catheter, Amplatz sheath, and inflation device. The Ultraxx Nephrostomy Balloon Catheter is constructed from a radiopaque nylon tubing with a dilatation balloon on its distal end. The outer diameter of the catheter is available in 6 French (Fr) with a working length of 55 centimeters (cm). The balloon of the catheter is constructed from polyethylene terephthalate (PET) and is available in nominal inflated diameters of 6 to 10 millimeters (mm) with a length of 15 cm. A radiopaque marker band is positioned on the distal end of the balloon catheter which confirms accurate placement of the catheter. The maximum rated balloon pressure is 20 atm. The Amplatz sheath is available in either polytetrafluoroethylene (PTFE) or a clear polyvinyl chloride (PVC). Both sheaths are available in inner diameters of 18, 24, or 32 Fr with a working length of 17 cm. The Cook Sphere Inflation Device was cleared on March 3, 2004 under K032840. The inflation device is a one-piece, plastic, disposable inflation device with a lock lever design to control the piston, a manometer, and a connecting tube with a male rotating adapter. The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.