§ 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).