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The Medline Integrated Arterial Catheter permits access to the peripheral arterial circulation system for short-term access (less than 30 days).

The Medline Integrated Arterial Catheter is a single-use device supplied sterile and nonpyrogenic; it will be packaged inside convenience kits alongside various components outside the scope of this 510(k) submission. The proposed device is a single lumen peripherally inserted catheter device designed to permit short-term access to the peripheral arterial circulatory for less than 30 days. The device assembly comprises a 20-Gauge catheter, 22-Gauge introducer needle, and a 0.018" guidewire with slide advancer. The catheter is made of radiopaque polyurethane tubing, echogenic needle, and removable stainless steel guidewire with slide advancer. The subject device has a kink-resistant catheter design. The device features dual flash with two distinct points of visualization, one with the clear introducer needle proximal hub and the second point at the notch cutout in the needle shaft. The final finished device is packaged with a suture wing (ALCS004). The suture wing is a Class I, 510(k) exempt device.

The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.

The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents. The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement. The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory). The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical. The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device: 1) Wireless Pressure Receiver - GE Monitor (CWMG001-5) 2) Wireless Pressure Receiver Philips Monitor (CWMP001-5)

The Centurion® Pressure Injectable Extension set intended for the delivery and /or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

The Centurion® Pressure Injectable Extension set intended for the delivery and/or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second. Centurion® Pressure Injectable Extension Sets consist of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer. They are configured with female luer locks on the proximal and distal ends, respectively, and are available in straight, Y, and T configurations. A slide or snap clamp may be positioned over the tubing to obstruct the fluid flow when needed. The Centurion® Pressure Injectable Extension Set is available in configurations with and without a needlefree valve. These valves are separately marketed devices and the applicable 510(k)'s are maintained by the respective manufacturers. The Centurion® Pressure Injectable Extension Sets are prescription devices provided sterile and nonpyrogenic for single use only and may be packaged individually or in medical convenience kits.