Title 21: Food and Drugs
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/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart B - Cardiovascular Diagnostic Devices / § 870.1220 Electrode recording catheter or electrode recording probe.
§ 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).