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The RadialSeal™ Introducer Kit is used to facilitate placing a catheter through the skin into the radial artery.

The RadialSeal™ Introducer Kit consists of an introducer (a sheath and a dilator), and either a needle or a stainless steel guidewire or an IV catheter with a plastic guidewire which has a pre-shaped distal tip. The kit is used to facilitate placing a catheter through the radial artery. The thin-walled introducer sheath is coated for reduced friction and has a hemostasis valve to minimize blood loss and air intake. The side port on the introducer sheath hub has a 3-way stopcock for flushing and infusion. The dilator and sheath cannula contain radiopaque material for visualization under fluoroscopy. An entry needle is provided to facilitate entry into the vessel. The entry needle is offered in either a stainless steel bare version, or as part of an IV catheter. A guidewire (0.021" diameter) is inserted through the bare entry needle or the cannula of the IV catheter, and maintains access to the puncture site upon removal of the needle and before insertion of the introducer (sheath and dilatorassembly). A dilator facilitates the entry of the sheath introducer by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The introducer is inserted over the guidewire and through the skin into the radial artery. Once the introducer is situated in the vessel, the dilator and guidewire are removed to allow access by the treatment device(s). The introducers are available in French sizes of 4, 5, and 6, and in lengths of 10, 16, and 25cm. The 0.054 cm (0.021" diameter) guidewire is available in either 45 cm (17.7 in) or 80 cm (31.5 in) length, and is comprised of either stainless steel spring coil or plastic (poly-jacketed Nitinol) material.

The MobiCath Transseptal Needle is used to create the primary puncture in the interatrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

The MobiCath Transseptal Needles consist of a thin-walled stainless steel cannula bonded to an ergonomic handle and stopcock, and a removable stylet. The cannula is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with an introducer or catheter. The handle is integrated with a pointer to show the orientation of the curve. The two-way stopcock facilitates air aspiration, fluid infusion, blood sampling, and pressure monitoring. The stylet attaches to the proximal end of the needle assembly.

The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.

The Z°Flex-270™ Steerable Sheath is a 12 Fr percutaneous steerable sheath with a flexible tip designed for gaining access to the vasculature including the coronary systems. It is comprised of two (2) main sections: the shaft and the handle. The Z°Flex-270 Steerable Sheath has uni-directional adjustable tip geometry with a rotating mechanism on the handle used to control sheath deflection. A dilator and guidewire are included with each kit.

The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.

The RadialSource™ Transradial Access (TRA) Kit consists of a catheter sheath introducer (CSI), a vessel dilator, a mini-guidewire, and an IV catheter (consisting of an IV cannula and a needle). The CSI is intended to facilitate percutaneous introduction of intravascular devices in arterial or venous procedures through, but not limited to, a radial approach. The vessel dilator and mini-guidewire are used in conjunction with the CSI to gain access to the vasculature. The CSI and vessel dilator contain a lubricious coating intended to reduce friction during insertion into the vessel. The CSI contains a hemostasis valve at the proximal end which minimizes blood loss and air intake to the vasculature. A sideport infusion line extends from the CSI proximal hub and terminates at a 3-way stopcock with a standard luer fitting for flushing/infusion. The CSI and dilator contain radiopaque material for visualization under fluoroscopy.

The MobiCath™ Transseptal Needle is used to create the primary puncture in the inter-atrial septum to facilitate the passing of an introducer or catheter through the septum from the right side of the heart to the left side.

The MobiCath Transseptal Needle consists of a thin-walled stainless steel cannula which is curved in the distal section to facilitate positioning in the cardiac anatomy when used in conjunction with a transseptal catheter or introducer. The proximal end of the needle is bonded to an ergonomic handle with an integrated pointer to show the orientation of the curve section and a two-way stopcock to facilitate air aspiration, fluid infusion, blood sampling, and pressure monitoring. The Transseptal Needle includes a stylet with an over-molded hub designed to attach to the proximal end of the needle assembly.

The Bidirectional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The MobiCath™ Bidirectional Guiding Sheath is an 8.5 French, flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry that allows deflection of the distal portion of the device bi-directionally 150°. This feature provides steerability to facilitate the delivery of therapeutic devices into the heart including the left atrium, using minimally invasive techniques. The sheath is fitted with a hemostatic valve which minimizes blood loss and air intake by providing hemostasis sealing to venous pressures as well as reduce dilator insertion and removal force. The sheath is also equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath and dilator contain radiopaque material for visualization under fluoroscopy.

The PTFE Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Greatbatch Medical PTFE Peelable Introducer Kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire. The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.

The OptiSeal™ Valved PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer, available in non-sideport and sideport configurations, is a small diameter tubular shaped device with integrated proximal handles. Both configurations of the OptiSeal Valved PTFE Peelable Introducer are designed to provide a relatively atraumatic method for insertion of catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. Both introducer configurations peel away after use allowing the user to remove the introducer without removing the inserted catheter or pacing lead. The sideport configuration of the OptiSeal Valved Peelable Introducer is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The OptiSeal Valved PTFE Peelable Introducer is packaged in sterile convenience kits containing a Valved PTFE Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The convenience kits are packaged five (5) per box.

The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Greatbatch Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire. The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated. The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.