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Phasix™ ST Umbilical Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving the repair of umbilical hernias.

Phasix™ ST Umbilical Hernia Patch is a sterile, single-use device for prescription use only. It is a self-expanding, fully resorbable mesh with a resorbable hydrogel coating and a positioning pocket and strap. Phasix™ ST Umbilical Hernia Patch is comprised of 2 layers of poly-4hydroxybutyrate (P4HB), with the posterior side being co-knitted with polyglycolic acid (PGA) fibers, identical to the mesh component of the secondary predicate device (Phasix™ ST Mesh with Open Positioning System). P4HB degrades through hydrolysis and a hydrolytic enzymatic digestive process and is essentially completely resorbed in 12-18 months. Phasix™ ST Umbilical Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) based hydrogel. The hydrogel is identical to both the primary predicate device (Ventralex™ ST Hernia Patch (K101928) and the secondary predicate device (Phasix™ ST Mesh with Open Positioning System, K190185). The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth. The visceral side of the mesh is the resorbable hydrogel coating, which separates the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration in saline, the coating becomes a hydrated gel that is resorbed from the site in less than 30 days. Phasix™ ST Umbilical Hernia Patch contains SorbaFlex™ Memory Technology, which provides memory and stability to the mesh, facilitating ease of initial insertion, proper placement and fixation of the device. The SorbaFlex™ Memory Technology is comprised of an extruded polydioxanone (PDO) resorbable monofilament contained within a knitted P4HB containment sleeve. PDO is resorbed within 24-32 weeks. The PDO ring and hybrid positioning straps (comprised of P4HB and polypropylene materials that are connected by overlapping the materials and sewing them together with clear PP monofilament, with a delineation marker dyed blue with [phthalocyaninato(2-)] copper), are based on the design of the primary predicate Ventralex™ ST Hernia Patch (K101928). The subject device has the identical intended use as the primary and predicate devices; soft tissue repair/reinforcement.

The AccuCath Ace™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used for adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels, with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath Ace™ IV Catheter is suitable for use with power injectors.

The AccuCath Ace™ Intravascular Catheter system consists of a radiopaque catheter with a valve mechanism delivered over a guidewire with an atraumatic tip design; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries. The AccuCath Ace IV Catheter is designed to reduce blood exposure during insertion, for use with ultrasound, and for use with the Cue Needle Tracking System.

Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.

The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.

The SiteRite™ 9 Ultrasound System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. Specific clinical applications include: - · Pediatric - · Peripheral Vessel and Vascular Access - · Small Organ (breast, thyroid, parathyroid, testicles) - · Musculo-skeletal (conventional and superficial) - · Cardiac (adult and pediatric) The SiteRite™ 9 Ultrasound System is indicated for Vascular, Vascular Access, Interventional, and Superficial Imaging Applications. Typical examinations performed using the SiteRite™ 9 Ultrasound System include: Vascular: Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access. Interventional: Guidance for biopsy and drainage. Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures.

The subject device, the SiteRite™ 9 Ultrasound System ("SiteRite 9 System") is a portable device that features real-time 2D ultrasound imaging for vascular access device placement, which includes vessel measurement tools, vascular access device selection, procedure documentation and electronic connectivity. The subject SiteRite 9 System is intended to aid in the placement of peripheral and central line vascular access devices and ultimately increase first stick success. The system is the replacement platform for the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (i.e., the predicate device) and includes more up-to-date and reliable components aimed at providing improved image quality, while maintaining ease of operation. The subject SiteRite 9 System can be viewed as the next generation SiteRite™ ultrasound system and is equivalent from a functionality standpoint to its predicate device, to the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281). The SiteRite 9 System is essentially replacing its predicate device, the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology ("Site~Rite 8 System"), due to the end-oflife obsolescence of its components. The subject SiteRite 9 System differs from its predicate device, the Site~Rite 8 System (K182281). in that it includes newer, more "state of the art" hardware components resulting in a more efficient and reliable use of the device. Aside from these technical upgrades, most of the previously cleared features of the predicate device are being brought forward. The subject SiteRite 9 System includes the following main components: - Ultrasound System Console - Ultrasound Beamformer - System Software - 9 Ultrasound Probe Additionally, the subject SiteRite 9 System is compatible with the following accessories: - SiteRite™ Probe Cover Kits - Site~Rite® Needle Guide Kits - Pinpoint TM GT Needle Guide Kits - MER Roll Stand with Mounting Accessory (optional accessory) - Kickstand with Mounting Accessory (optional accessory) - Sony Printer UP-X898MD (off-the-shelf, optional accessory) - USB Storage Device (off-the-shelf, optional accessory)

The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system. The 6F and 8F Aspirex™ Thrombectomy Systems are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.

The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration. The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use. The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause damage to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus.

The Highlander™ 014 PTA Balloon Dilatation Catheted for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal and renal arteries. This device is also indicated for post-dilatation of balloon expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Highlander™ 014 PTA Balloon Dilatation Catheter is a small vessel balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100mm and greater, two radiopague markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheters include an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. A silicone-based, hydrophobic coating is present on the distal segment of the shaft and balloon. Highlander™ 014 is compatible with 0.014" guidewires. The proximal portion of the catheters include a female luer lock hub connected to the inflation lumen, and a female luer lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex. The GeoAlign™ Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GeoAlign™ markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GeoAlign™ Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GeoAlign™ Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign™ Marking System.

The WavelinQ™ Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The WavelinQ™ Generator is a high frequency isolated generator that utilizes electrical current to deliver radiofrequency (RF) energy to the catheter electrode for formation of a vascular fistula. The generator offers a receptacle for a monopolar handpiece. The WavelinQ™ Generator is intended to be used with the currently marketed and cleared device WavelinQ™ EndoAVF System (K192239). The generator has one setting (AV1) equivalent to the mode (Cut T, 60W, 0.7s) of the predicate device, ESU-1 Electrosurgical Generator, that is used during the WavelinQ™ EndoAVF System procedure. This mode is set to deliver energy at 60 Watts for 0.7 seconds. The generator has a return electrode contact, for use with a split ground pad, and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use only a split return electrode, also referred to as a split ground pad. The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, LED numeric display, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of volume controls, a power cord outlet and fuse, and internal components (printed circuit boards, speakers, cabling).

The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.

The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use. The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus. The Aspirex™ Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated tungsten tip coated with DSM ComfortCoat® hydrophilic coating. The guidewire is used to initially cross through the area to be treated.

The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied guidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40,000-60,000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip. The Rotarex™ Atherectomy System Guidewires are 0.018" and are included with each Rotarex™ Atherectomy Catheter Set. These guidewires consist of a Nitinol core and a PTFE coating with a 9.5cm hydrophilic distal coating and a 4 cm angled flex tip. All components within the Rotarex™ Atherectomy Catheter Sets are supplied sterile for single use only. The method of sterilization is ethylene oxide.