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The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.

The PhasTIPP System consists of an Illuminator and a Resector. During the surgical procedure, the illuminator shaft is placed through an incision under the skin with its light-emitting end to provide intense light for a better visualization of the varicose veins. A port that runs along the illuminator shaft is used to infuse tumescence solution to cause the contraction of varicosities, which aids vein visualization by creating a subcutaneous fluid pocket through which the illuminator's light can disperse. A powered resector, positioned through a different incision can then be used to morcellate and aspirate the varicosities. The PhasTIPP Illuminator consists of two devices: a reusable Illuminator Handpiece and a disposable Illuminator. The Handpiece provides illumination controls and contains an LED to provide intense light. The Handpiece is powered with new batteries for each new surgical procedure (Duracell CR 123a cell). The handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Illuminator in the sterile field before the procedure begins. The Disposable Illuminator includes, in addition to the microbial barrier sheath, a distal stainless steel fiber optic light shaft. When connected to a peristaltic pump, the Disposable Illuminator can also infuse tumescence. The PhasTIPP Resector consists of two devices: a reusable Resector Handpiece and a Resector Disposable (available in two diameters, 4.5mm and 5.5mm). The Disposable Resector also connects to a peristaltic suction pump to remove the resected varicosities. The Resector Handpiece provides controls for the operation of the rotation blades on the Disposable Resector and is powered with a set of new batteries (TLM-1550 HPM cell), for each surgical procedure. The Resector Handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Resector in the sterile field. The Control Unit that was a large equipment in the predicate device is displaced in the subject device. Instead, the Resector Handpiece and the Illuminator Handpiece control the disposable resector and illuminator in the subject device.

The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

The XenoSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. XenoSure patch is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution.

The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.

The EZE SIT Valvulotome is a medical device utilized for disruption of venous valves, and is used in patients that suffer from peripheral vascular disease, for which an attending physician determines the relative benefit of in situ bypass to restore blood flow to the extremities. The EZE-SIT Valvulotome is comprised of a catheter with a luer-lock hub at the proximal end and a threaded connector at the distal end. The catheter is designed with a lumen that extends throughout its entire length. The threaded connector allows attachment of 2 mm, 3 mm and 4 mm diameter cutting heads. These cutting heads are also configured with a central lumen. This design allows the physician to select the cutter head diameter that is best suited for the particular vessel being prepared. The central lumen allows irrigation during the procedure. The cutting head design minimizes vessel wall contact while effectively disrupting valve leaflet tissue. The EZE SIT Valvulotome is surgically invasive and intended for less than 24-hour use. This medical device has no software components. This device is not an in vitro diagnostic device.

The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.

The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.

The Pruitt F3 Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

The Pruitt F3 Carotid Shunt is used in patients with carotid artery disease in instances where removal of vascular occlusions is the therapeutic objective. The Pruitt F3 Carotid Shunt is employed in Carotid Endarterectomy (CEA), where the shunt is used as a short-term conduit for blood flow between the common carotid and the internal carotid arteries. The Pruitt F3 Shunt is provided sterile for single use, and is provided with two 3 ml syringes used to inflate the balloons (accessory syringes have been previously cleared in K051067). The Pruitt F3 Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. The Pruitt F3 Shunts are multi-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon.

The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired. The Applier is also intended for approximation of durotomies following open craniotomy and open spinal laminectomy procedures.

AnastoClip GC Closure System is designed to create everting anastomoses of tissue. It includes the applier, clip remover, and atraumatic forceps. The AnastoClip GC applier consists of a rotating shaft and an integral cartridge containing titanium clips. As the levers of the applier are squeezed together, the clip is closed around the everted tissue edges. As the levers are released, a new clip is automatically loaded into the clip applier jaws. It is recommended, with each procedure, to use the atraumatic everting forceps to aid in the everting of the tissue edges. It is also recommended, with each procedure, to use the AnastoClip Remover for the removal of any AnastoClip GC clips when needed.

The Pruitt F3-S Polyurethane Carotid Shunt is in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

The Pruitt F3-S Polyurethane Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Polyurethane Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The Pruitt F3-S Polyurethane Carotid Shunt is not made of natural rubber latex.

The Pruitt F3-S Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

The Pruitt F3-S Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. The Pruitt F3-S Shunts are multi-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon.

The LeMills Valvulotomes are intended to cut venous valves.

The Antegrade LeMills Valvulotome consists of small metal antegrade cutting blade with atraumatic distal edge. The blade is a part of a long stainless steel wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.

It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.

The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.