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The Arrow Pressure Injectable JACC with Chlorag+ard Antithrombogenic Technology is indicated for short-term (<30 days) or long-term (>30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa), The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathyav of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness were evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treating infections. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in palients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology has the following characteristics: - . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter with or without preloaded VPS stylet - 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic . catheter with or without preloaded VPS Stylet - 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic ● catheter with or without preloaded VPS Stylet The subject device is a CG+ Arrow JACC with or without pre-loaded Arrow VPS Stylet and will be provided in sterile kit configurations. The modifications subject to this submission are additions to the recommended procedural technique to clarify that the catheter devices can be trimmed or cut to the appropriate length based on the specific patient's anatomy. The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-Lumen and 2-Lumen catheters and 6 mL/sec for the 3-Lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag+ard technology. There are no modifications subject to this premarket notification related to the geometric or material design of the devices modified in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.