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The Nest VT Vitrification Device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.

The subject devices, Cook Nest VT Vitrification Devices, are sterile, single-use assisted reproduction storage devices for use in vitrification procedures to contain and maintain oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. The Cook Nest VT Vitrification Devices are composed of a stick (124.5 mm) and cap (38.5 mm) design with a combined length of 136.5 mm, a 35 mm space for notations, and a 6 mm long loading well. Visible marks are on the distal tip end, on the body of the stick and at the opening of the cap, which are created through laser etching to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The stick and cap include a taper design that create a seal when assembled. All the subject devices included in this submission are identical except for their color. There are 5 different colors: blue, purple, red, yellow, and green. The subject devices are sterilized using gamma radiation to a sterilization assurance level of 10-9, are one-time use, and have a 2 year shelf-life. During the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick and the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage.

The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

The Günther Tulip Vena Cava Filter Retrieval Set is composed of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath. The Günther Tulip Vena Cava Filter Retrieval Set is intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.

The Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.

Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular applications in the arterial system.

Endovascular Dilator and Sets are manufactured from vinyl radiopaque dilator tubing and consist of either one or two dilators that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into an artery for vascular clinical applications that require percutaneous access. The serial dilator components are designed with long, gradual tapers and include hydrophilic coating, and are available in various inner and outer diameter and length combinations.

Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.

Cook Incorporated's Extra Large Check-Flo® Introducer is a single-use, sterile, disposable product that is used to introduce therapeutic or diagnostic devices into the vasculature. The Extra Large Check-Flo® Introducer consists of an introducer sheath, Check-Flo® hemostatic valve assembly, and dilator. The sheath is constructed with a hemostatic valve that accepts a large range of French sizes while preventing blood reflux and air aspiration. The subject device, the Extra Large Check-Flo® Introducer, is manufactured in diameters of 20.0, 22.0 and 24.0 French with sheath lengths of 25, 40, or 65 centimeters. The dilator is manufactured in lengths 16 centimeters longer than the sheath (41, 56, and 81 centimeters, respectively). The diameter of the distal endhole of the dilator measures 0.035 inch. The introducer sheath and dilator are matched as a unit to provide a smooth transition.

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.

Intended for the intravascular introductional devices into the peripheral, including pulmonary, vasculature.

Lumax® Guiding Catheters are conduits introduced, either singly or as a coaxial pair, into a vein or artery and tracked over a wire guide to the site of a vascular lesion where interventional devices can be delivered through the guiding catheter's internal lumen for treatment. The Lumax® Guiding Catheters may include either a single guiding catheter or a coaxial catheter pair (composed of an outer guiding catheter and an inner coaxial catheter). The single guiding catheters are available in a 7.0 French outer diameter in lengths of 80 or 90 cm. They are manufactured with a multilayered braided nylon shaft, bonded Luer hub, and radiopaque tip. The guiding catheters are designed with a multipurpose (MPA) distal curve configuration. The coaxial catheter pair comprises an outer guiding catheter matched to an inner coaxial catheter. The guiding catheter component is available in an outer diameter of 8.0 French and a length of 80 cm. The inner coaxial catheter is manufactured from radiopaque braided nylon tubing and has an outer diameter of 6.0 French and a length of 100 cm. For lubricity, the distal 40 cm of the inner catheter is treated with hydrophilic coating. The Lumax® Guiding Catheters are supplied as packaged, sterile devices, intended for single-patient use.

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray are designed for percutaneous dilational tracheostomy for management of the airway. The devices allow for single-stage dilation, which is achieved with a single rhino-horn-shaped dilator using an in-andout motion. Sets and trays include a Blue Rhino G1 Dilator or Blue Rhino G2 Dilator, loading dilators (6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm) an 8 Fr guiding catheter, a 14 Fr access dilator, and a wire guide. Sets and trays are available in multiple configurations, which include various set and tray components (Table 1) associated with the procedure and/or for gaining percutaneous access. The subject device Weinmann-Multi Tracheostomy Exchange Set is comprised of a Blue Rhino G1 Dilator, loading dilators (7.0, 7.5, 8.0, 8.5, and 9.0 mm), an 8 Fr Cook Airway Exchange Catheter, and two Rapi-Fit Adapters.

Used to temporarily occlude the ureteropelvic junction to prevents from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.

The UPJ Occlusion Balloon Catheter is composed of a balloon catheter, a removable inflation/injection adapter, a 1 mL syringe, and a wire guide assembly. The UPJ Occlusion Balloon Catheter is manufactured from a double lumen polyurethane radiopaque tubing with a working length of 75 centimeters. The smaller lumen is designed for balloon inflation, while the larger lumen fits over the wire guide assembly. The distal balloon is manufactured from silicone and has an approximate inflation volume of 4 mL. The inflation/injector adapter is removable, allowing for a cystoscope to be removed after the catheter is in place. The wire guide assembly is manufactured in 0.028- or 0.038-inch diameter stainless steel coils. The stainless-steel coils are coated with polytetrafluoroethylene and measure 80 centimeters. The wire guide assembly is designed to be placed through the small lumen of the balloon catheter. The UPJ Occlusion Balloon Catheter is supplied sterile, intended for one-time use only, and packaged in a peel-open pouch with a shelf-life of 3 years.