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For use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes.

The 200mL Syringe for Stellant Injectors are syringes / kits intended for use with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes. Each configuration is listed below in the "Models"section and provided sterile. To further define the device, the kits may include (depending on package configuration) extension lines, fill tubes, prime tubes, and spikes. The extension lines are used to connect the svringe to a patient's IV. The prime tube is used for catching fluid while purging air from the extension line. The fill tubes and spikes are used to connect the syringe to contrast media or saline containers for filling. The Fascia (installed on the surface of the injector case and through which the ram/ram tip moves) and the RamTip (connected to the injector ram and to which the syringe is connected), used in adapting the Medrad* Stellant* Injector for use with the Coeur 200mL Syringe for Stellant Injectors are not sterile, and after installation onto the injector, remain installed as long as the Coeur 200mL Syringe for Stellant Injectors is used with the injector. (Cleaning instructions for the Fascia and Ram Tip are provided in the IFU.) Principle of operation- The syringe plunger is engaged by the equipment ram and moved forward and back for filling and injection purposes.

For use with the Medrad Spectris® Solaris™ MR Injection of contrast media or saline to the vascular system for diagnostic purposes.

The MR Syringes for Solaris Injectors (65mL and 115mL syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered: i. C853-2201 65mL and 115mL Syringe with 96" Coiled extension Y~Line and Fill Spikes ii. C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes iii. C853-2203 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Fill Spikes iv. C853-2204 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Contrast and Saline Spikes v. C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension Y~Line and Fill Tube vi. C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube

The 330psi Extension Y-Line with Dual Check Valve is to be used as an interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

The 330psi Extension Y -Lines with Dual Check Valves will be offered in the following configurations: i. 60" 330psi Extension Y-Line with Dual Check Valve (C405-1569) ii. Short 330psi Extension Y-Line with Dual Check Valve (C405-2042) iii. 60" 330psi Extension Y~Line with Dual Check Valve and Linden Adapters (C405-2155) iv. 96" 330psi Extension Y-Line with Dual Check Valve (C405-2962)

For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.

The 125mL CT Syringe will be sold as a single syringe. The following configurations may also be offered: i. 125mL Syringe and Fill Tube ii. 125mL Syringe with Coiled Line and Spike iii. 2 125mL Syringes with 2 Spikes iv. 125mL Syringe and Coiled Extension Line v. 2 125mL Syringes with Extension Y-Line and 2 Spikes

For use with the LF OptiStar Injector for injection of contrast media or saline.

The MR Syringe is a pack that includes two 60ml MR Syringes, a 96" coiled Y-Line, and two Lateral Flow Needle Spikes. The alternate configuration of the MR Syringe is a pack that includes one 60mL MR Syringe, a 60" Coiled Line, and one Lateral Flow Needle Spike. Each of the components to be used in the proposed device has been cleared for marketing under previous 510(k) submissions.

For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes

The proposed device is a Front Load Adapterfor Liebel-Flarsheim Optivantage DH Injector. As defined by 21 CFR 870.1650, an angiographic injector and syringe is a device that consists of a syringe and a highpressure injector which is used to inject contrast media into the heart, great vessels. and coronary arteries to study the heart and vessels by x-ray photography. The Coeur adapter is a unit designed to install onto legally marketed power injectors to enable use of the Coeur syringe with such injectors. It includes a component that affixes to the ram of the power injector to adapt it to fit the plunger of the Coeur syringe.

to be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

Disposable, 330psi Extension Lines

to facilitate manipulation of a guide wire during a vascular procedure

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to maintain a fluid-tight seal around interventional and diagnostic devices while allowing control/manipulation of such devices during use

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for injecting contrast media and saline, for angiography

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