§ 870.1200. Diagnostic intravascular catheter.
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/us/cfr/t21/s§ 870.1200·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
(b)Classification. Class II (performance standards).