§ 870.1650 - Angiographic injector and syringe.  


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  • § 870.1650 Angiographic injector and syringe.

    (a) Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

    (b) Classification. Class II (performance standards). special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

    [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]