21 C.F.R. § 870.1220

Current through September 30, 2024
Section 870.1220 - Electrode recording catheter or electrode recording probe
(a)Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
(b)Classification. Class II (performance standards).

21 C.F.R. § 870.1220