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The VersaCross Connect Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) is a single-use device that is supplied sterile to the user. The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720). The VersaCross Connect™ Transseptal Dilator (VXA-AG) is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures. The dilator can be used with separately cleared compatible access sheaths such as Agilis™ NxT Steerable Introducer (K061363 or K081645). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum. The subject device can be used by electrophysiologists, interventional cardiologists, and other users trained in catheter techniques for any procedure that requires left atrial access via transseptal puncture. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.

The Merit Micro Ace™ Gold Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Gold Advanced Micro Access System (hereafter referred to as Micro Ace™ Gold) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wires. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018” (0.46mm) guide wire. The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: Some catalog codes will include a nitinol wire with platinum guidewire tips; Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.

The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.

The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years. The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021. The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm. The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990). The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.

The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A guidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire. The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures. The dilator can be used with separately cleared compatible access sheaths such as CARTO VIZIGO™ Bi-Directional Guiding Sheath (K231412). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.

The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The device is comprised of a single dilator. The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A quidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire. The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures. The dilator can be used with separately cleared compatible access sheaths such as FARADRIVE™ Steerable sheaths. The dilator may also be used as a standalone device to facilitate access to the left atrium following transseptal puncture. The dilator provides support and helps quide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.

The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.

The Merit Micro Ace™ Advanced Micro Access System (hereafter referred to as Micro Ace™) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018" (0.46mm) guide wire. The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires: • Some catalog codes will include a nitinol wire with platinum guide wire tips; • Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.

The TightRail Guardian motorized dilator sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

The TightRail Guardian motorized dilator sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of: 1. Drive Assembly 2. Dilation Extension Selection (DES) Assembly 3. Motor Drive Handle 4. Outer Sheath Accessory 5. Fish Tape Accessory The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for quidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads.

The TightRail Guardian Motorized Dilator Sheath is a sterile, single use, prescription only device used for cardiac leads. The device is comprised of: 1. Drive Assembly 2. Dilation Extension Selection (DES) Assembly 3. Motor Drive Handle 4. Outer Sheath Accessory 5. Fish Tape Accessory The motorized dilator sheath is advanced or retracted along the target lead to be removed. Pulling the trigger on the handle of the TightRail Guardian device results in activation of the motor and subsequent rotation of the inner shaft and cam blade. Triager activation results in bidirectional rotation mechanism. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the lead tarqeted for removal, thereby facilitating removal of said lead. The device has two modes of operation, providing dilation with the blades shielded or extended. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Guardian is 47.5 cm. The outer sheath accessory may be used for additional support by creating a conduit for the device's shaft assembly. The outer sheath may also be used to maintain venous access for guidewire placement, prior to implantation of a new lead. The fish tape accessory may be used to feed a target lead and locking stylet through the inner lumen of the device.

The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired

The subject device is comprised of the following components, which are single-use and supplied sterile to the user: - One Dilator - One J-tipped Guidewire The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the legally marketed ExpanSure™ Large Access Transseptal Dilator (K201288) (comprising a dilator and J-tipped Guidewire). The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation. The dilator can be used with separately cleared compatible introducer/access sheaths such as WATCHMAN™ Access sheaths. The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.