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The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

The Halo One Thin-Walled Guiding Sheath consists of a thin-walled (Up to 1F reduction in outer diameter compared to standard sheaths of equivalent French size) sheath made from single-lumen tubing, fitted with a female luer hub at the proximal end and a formed atraumatic distal tip. The thin-wall design reduces the thickness of the sheath wall to help facilitate intravascular access from access sites including but not limited to radial, femoral, popliteal, tibial and pedal. A detachable hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, is connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip. The Halo One Thin-Walled Guiding sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm. 70cm. 45cm. 25cm and 10 cm. The Halo One Thin-Walled Guiding Sheath 4F, 5F and 6F 25cm and 10cm sheaths will be offered with a 0.018" and 0.035" guide wire compatible dilator option. The Halo One Thin-Walled Guiding Sheath is also offered as an access kit in 4F,5F and 6F 10cm and 25cm lengths incorporating access needle (21G x 4cm or 19G x 7cm option available) and access guidewire in both 0.018" (0.018" x 80cm or 0.018" x 50cm option available) and 0.035" (0.035" x 80cm or 0.035" x 50cm option available) configurations to the existing predicate device product range. All sheath configurations (lengths) are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The shorter sheath configurations (25cm and 10cm) are also provided without the coating.

The AccuCath™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath™ IV Catheter is suitable for use with power injectors.

The AccuCath™ Intravascular Catheter has usable length catheters of 1.25 and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The AccuCath™ IV Catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. The AccuCath™ IV Catheter is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, and a guidewire within the lumen of the needle which is connected to a slider, spring and release button.

Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open-ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.