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

The Enpath 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 7F (micro) and 7F through 16.5F (macro). The dilator is designed to be delivered over a 0.018" guidewire (micro) up to a 0.038" guidewire (macro). 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 Percutaneous Introducer sheath has a "tear-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The kit is packaged in a tray and placed into a poly-Tyvek pouch and sealed.

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

The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and 7F (macro) in lengths of 5cm or 10cm. The sheath handles are color coded for identification of French size. The locking configuration has been modified on the sheath and dilator to an annular snap fit. The dilator will lock into the hub without the use of a rotating collar allowing the user to lock and secure the dilator to the sheath.

The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

The Coaxial Micro-Introducer Kit contains a 21 gauge disposable aspiration and injection needle, a 0.018 inch diameter guidewire, and a coaxial micro-introducer set consisting of a dilator and sheath available in 4F, 4.5F, or 5F. The modified device contains the same kit configuration as above except that the dilator and sheath are available in 4F or 5F. The inner dilator includes a stainless steel stiffening hypotube. The inner and outer dimensions of the dilator remain the same as the currently marketed Coaxial Micro-Introducer Kit.

The Enpath ViaSeal Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Enpath ViaSeal Valved Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The ViaSeal Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. The ViaSeal Valved Peelable Introducer has a "peel-away" feature common to the predicate device. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The ViaSeal Valved Peelable Introducer is packaged in a sterile 5-pack convenience kit containing a ViaSeal Valved Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The kit is packaged in a PETG tray with a Tyvek lid, and a sealed Tyvek/LDPE pouch. Introducer sizes of the sheath and dilator range from 7 French to 10.5 French. The materials and construction are the same for all French sizes. Enpath ViaSeal Valved Peelable Introducer kits will be packaged and ETO sterilized for one time use and sealed in a Tyvek/LDPE pouch.

The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

The Enpath Steerable Sheath is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve.