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The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75″, lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.

The TorFlex Transseptal Guiding Sheath is indicated for the percutaneous introduction of various devices into heart chambers, including the left atrium via transseptal puncture/perforation.

TorFlex Transseptal Guiding Sheath

To facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

The products identified in this 510(k) notification are splittable, polyethylene introducer catheters. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate springactivated needle-shielding technology. The Autoguard component incorporates a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber and hydrophobic flow control plug, and a needle. The useractivated Autoguard™ product has a button, which the user pushes to initiate the needle's retraction into the needle-shielding barrel. The Introsyte introducers are available in sizes ranging from 14 to 24 gauge.

The GORE Introducer Sheath is used to facilitate the introduction of guidewires, catherers and other investible medical devices with such introduction.

The GORE Introducer Sheath is designed to provide easy access to the vascular system while providing convenient access to che vaborfally The device allows introduction of angiographic exchanges . catheters, balloon catheters, other relevant catheters, guidewires and endovascular devices into a vessel. The gardewired and theath is composed of biocompatable materials and is provided sterile. The GORE Introducer Sheath is comprised of the introducer file Gox introducer The introducer sheath is composed of a sheath, sheath hub and cap, and hemostasis valve. The dilator is composed of a dilator tube and dilator valve body .

Boston Scientific/EP Technologies Convoy™ Advanced Delivery Sheaths and accessories are designed to facilitate the intracardial placement of interventional devices. The sheath may be exchanged and placed in interventional position after transseptal puncture has been obtained using a different sheath.

The Soft Tip Intracardiac Introducing Sheath Kit consist of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.