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Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.

The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube, and spike. Syringe: The syringes are intended to be used with an U.S. legally marketed angiographic injector. Compatibility is shown in the Table 1 Compatibility between Syringe and Injectors. (Note: the newly added and the difference between K211564 and the proposed device is highlighted in Red.) Connection tube: it is used to connect the syringe and the catheter. The tubes (extension tube) are also available in various configurations, which are Type B (used with single shot syringe, highlighted in Red mark), renamed "Straight tube" to "Type B" and added a new model (400204) connecting tube in the Table. The product structure, manufacturing process, product materials have not changed. Type Y and type T tube are used with dual shots syringe. The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube. (Note: the newly added and the difference between K211564 and proposed device is highlighted in Red) J shape tube: it is used to draw contrast media/saline into the syringe barrel before installation. Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installation. The pressure specification for the spike is provided in the following table as Table 3 Pressure Specifications for Spike (Note: this model is only used to distinguish whether it is made with or without DEHP). The product materials, manufacturing process and product structure have not changed. Spikes not made with DEHP are marked with Red. The new additions of spike models are: 700204- 1, 700204-2,700205-1, 700205-2, 700206, 700207-1, 700207-2)

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline: they shall be used with US legally marketed angiographic injectors.

The subject devices are identical to all models of predicate devices of K192657. It includes disposable syringes, connection tube, J shape tube and spike. Labeling of subject device now includes pediatrics in the patient population.

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube and spike.