View all text of Subpart B [§ 870.1025 - § 870.1915]
§ 870.1200 - Diagnostic intravascular catheter.
(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).