Title 21: Food and Drugs
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/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart B - Cardiovascular Diagnostic Devices / § 870.1650 Angiographic injector and syringe.
§ 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 (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.