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The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen, a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the 6 Fr delivery catheter is 80cm and 120cm. The working length of the 7Fr delivery catheter is 120 cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device: a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver which deploys the stent distally relative to the Outer Sheath; and the System. Lock which eliminates the possibility. of premature deployment. The working length of the delivery catheter is 120cm. The SUPERA® stent housed within the 120cm SUPERA VERITAS® stent delivery catheter is a closed end interwoven self-expanding Nitinol stent. The SUPERA stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

The SUPERA™ VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends. The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.

SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thurnb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver which deploys the stent distally relative to the Outer Sheath; the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 120cm. The SUPERA® Stent housed within the SUPERA VERITAS" stent delivery catheter is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is indicated for use with the 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter was designed and is manufactured by IDev Technologies, Inc. for use with the FDA 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in the palliation of malignant strictures (neoplasms) in the biliary tree. It shares the same indication for use and design features as the Precision™ Stent Delivery Catheter (K060557) with the exception of modifications that do not significantly affect the function and/or safety of the device. Please refer to Figure 1. The SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is a 7 Fr, 0.018" guide wire compatible, multi-lumen sheath based delivery system comprised of an Outer Sheath (1) attached proximally to a Handle (2); a radiopaque Marker Band (3) located on the Outer Sheath that can be visualized under fluoroscopy to assist in system placement/SUPERA™ stent deployment; a Thumb Slide (4) connected internally to a means for advancing the SUPERA™ stent out of the Outer Sheath as the Outer Sheath moves proximally in a de-coupled fashion; a Stopcock (5) for flushing the central lumen of the device and for contrast injection; a Retention Cable (6) connected to the proximal end of a stent to assist in resheathing/repositioning the stent; a Resheath Collar (7) that can be actuated to allow for resheathing or deployment of a stent; a Torquer (8) connected to the Retention Cable for external visualization of the deployment process, a dedicated Guidewire Lumen (9) for traversing over an 0.018" guidewire with a radiopaque Flexible Tip (10) and Guidewire Luer Fitting (11), used for flushing the Guidewire Lumen, located on the distal and of the Guidewire Lumen, respectively; a Hemostasis Valve (12) that can be tightened to eliminate relative motion of the Flexible Tip with respect to the Outer Sheath; a Y-Port (13) housing the Retention Cable and serving as a point of reference for deployment; an introducer Valve Defeater (14); a Re-Sheathing Indicator (15); and a Packaging Mandrel (16).

The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is indicated for palliative treatment of biliary strictures produced by malignant neoplasms. The SureSave " Self-Expandable Biliary Nitinol Stent and Precision" Stent Delivery Catheter is intended for use in the palliation of malignant neoplasms in the biliary tree.

The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is comprised of two components; the implantable SureSave™ metallic stent and the Precision™ delivery system. The stent, provided pre-mounted on the delivery system, is a woven wire is constructed from a biomedical superalloy wire, braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, self-expanding and can withstand strong radial force. The delivery system consists of an inner and outer catheter. The exterior catheter serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. The inner catheter contains a central lumen which will accommodate a 0.018" guidewire.

The Texan LONGhorn™ Foreign Body Retrieval Device is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

The Texan LONGhorn™ is comprised of the following: - A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a catheter. The "loop" portion of the wire has a platinum core for enhanced radiopacity. - An inner member accepting an 0.018" guidewire. The proximal end of the inner carrier extends out the side port of a Y-connector allowing for the physician to manipulate the guidewire thru the device. - An outer member. The proximal end is connected to a hemostasis Y-connector, having a side port and Tuohy-Borst connector on the central port for securing the hypotube. - the Tuohy-Borst connector allows the physician to secure the loop size once it is deployed to the desired diameter - the side port of the Y-connector allows access to the guidewire-dedicated lumen and the T-connector to allow for contrast injection and flushing The loop is activated by moving the red capped knob and handle axially. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by retracting the red capped knob proximally while the device is held stationary in position. Once the loop is tightened around the foreign body, the handle and shaft shall be locked by rotating the hemeostasis valve connected to the proximal end of the handle clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan LONGhorn™ TX30120060 and the foreign body as a unit into the sheath.

The AKónya Eliminator Plus™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting native arterio-venous (AV) fistula and synthetic dialysis grafts.

The AKónya Eliminator Plus™ Mechanical Thrombectomy Device is comprised of three discrete elements: - . An outer member, connected distally to the proximal end of the thrombasket. The proximal end is connected to a hemostasis Y-connector, having a side port for flushing, and a Tuohy-Borst connector on the central port for securing to hypotube, as an aid for handling during the surgical procedure. - 트 An inner member, connected distally to the distal cnd of the thrombasket. Proximally, the inner member is connected to a handle. - 트 A thrombasket, composed of woven or braided stainless steel wire.

The Texan™ Foreign Body Retrieval Device is indicated for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

The Texan™ is comprised of the following: - A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a dedicated catheter lumen. The "loop" portion of the wire has a radiopaque feature, comprised of Nitinol wire with a platinum core and tungsten sheath - A two-lumen catheter body. One lumen is dedicated for use by the loop wire, which is secured to the push-rod (shaft) at the proximal end of the loop wire. The second and larger lumen is dedicated for use of a guidewire and contrast. The proximal catheter end is to be attached to a hemostasis valve with a flush port. - The hemostasis valve has 2 ports: - side port having access to the guidewire-dedicated lumen for contrast injection; and - primary port dedicated for a guidewire, and having a Tuohy-Borst connector. The loop is activated by pushing the shaft distal to the Touhy-Borst connector while holding the Touhy-Borst stationary. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by pulling the shaft proximally while the device is held stationary in position. Once the loop is tightened around the foreign body the shaft shall be locked by rotating the homeostasis valve connected to the proximal end of the shaft clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan™ and the foreign body as a unit into the sheath.