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The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.

The Arrow Stiffening Stylet is a sterile, single use, percutaneous peripheral vasculature catheter stylet intended for transient use (up to 24 hours) to be placed within a catheter to render it stiff to aid in catheter placement. The proposed device will be delivered as a sterile accessory within a convenience kit for the Arrow Peripherally Inserted Central Catheter (PICC)s. The Stylet is a PTFE coated solid nitinol core wire with straight tip. The stylet is available in 0.015-0.017-inch diameters and in 29.5-inch length with distance markings along the stylet body. The Arrow Stiffening Stylet is provided with an existing, commercially available flushable hub with side arm and slide clamp cleared under K790408. The flushable hub maintains the stylet position within the catheter during catheter placement, is intended to minimize blood loss during catheter introduction, and allows the clinician to flush through the catheter to aid in catheter placement, if needed. There is no change to the flushable hub cleared under K790408 introduced by this submission.

The BIOTRONIK Stylets are used in conjunction with the implantable systems (leads and pacemakers or ICD). Therefore, the same indications that apply for the designated active implant and leads, also apply for stylets.

BIOTRONIK stylets are intended for use with long-term implantable BIOTRONIK leads and are used during the implantation procedure of these leads. Stylets predominantly serve to stiffen the flexible lead during implantation in order to facilitate its positioning. BIOTRONIK stylets consist of metal wires of different stiffness, lengths and shapes that are attached to a small plastic handle on their proximal end to simplify the manipulation of the stylet during lead implantation. The plastic handle carries a color-code that indicates the stylet length and the stiffness. In addition, the wire diameter and the length of the stylet are printed on the handle.

The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.

The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).

The Liberator® Beacon® Tip Locking Stylet is intended for use in patients requiring the percutaneous removal of cardiac leads, indwelling catheters and foreign objects, with a central lumen.

The Liberator® Beacon® Tip Locking Stylet is a specialized stylet that can be inserted through a cardiac lead's inner conductor lumen, once the proximal connector has been removed. The stylet can then be locked into position within the lead's distal portion allowing for the delivery of tractional forces helpful during the extraction procedure. The Liberator Beacon® Tip Locking Stylet has a braided Nickel-Chromium integral extender (handle). The locking mechanism that is located at the distal end of the stylet is comprised of a uniquely shaped stainless steel wire-locking coil segment attached to a central stainless steel stylet wire. This locking stylet is activated through the forward advancement of a stainless steel cannula that surrounds the central stainless steel stylet wire. Upon activation by the cannula. the wire-locking coil segment at the distal end of the stylet is advanced forward and is compressed. This compression causes the stacking of successive helices of the wire-locking coil. This stacking results in the outward radial displacement of a number of the wire-locking coil's helices against and into the lead conductor coil through which it has been inserted. This outward radial displacement creates the locking engagement of the Liberator® Beacon® Tip Locking Stylet to the lead conductor central or inner lumen. The device is available in a single size compatible with the internal diameter dimensions of many leads and catheters with a central lumen. Stylet wires for checking lead patency are available separately; they consist of a molded plastic handle on a 0.038 cm (0.015 inches) stainless steel wire, with a wire length of 65 cm.

The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.

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The stylet is intended to aid in the placement of St. Jude Medical transvenous leads.

The document describes several models of stylets made of stainless steel with molded ABS thermoplastic hubs. They vary in diameter, flexibility (soft, firm, extra firm, extra soft), and length. Some models are ball-tipped. Accessory kits may include tools like a fixation tool or clip-on tool, and a stylet ring holder. The Locator Plus stylet is a deflectable implantation tool.

The St. Jude Medical Mond™ RVOT Stylet is designed to place SJM right ventricular active fixation leads in the right ventricular outflow tract.

The St Jude Medical (SJM) Mond RVOT Stylet is an accessory implant tool, intended for use in the placement of SJM right ventricular active fixation leads. The Mond stylet is configured in a modified "J" shape designed to position the leads in the RVOT. The stylet uses the same materials and similar manufacturing processes as the currently approved J (4090 and 4091) bradycardia stylets and the S-75-X tachycardia stylets.

The CPS DuoTM guidewire and stylet are indicated for: Facilitation of placement of St. Jude Medical left heart leads to target vessel/site.

CPS Duo™ Left Heart Lead Delivery System is a combination of a CPS Duo™ Stylet and a CPS Duo™ Guidewire designed to facilitate the delivery of a SJM lead to the target vessel/site. The CPS Duo™ stylet has a lumen to allow a CPS Duo™ guidewire to pass through it. The CPS Duo™ Guidewire is specially designed to function in concert with the CPS Duo™ Stylet.

For use with compatible, transvenous, left ventricular, pace/sense leads

The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths). The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.

The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.

The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads. The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.