Electrode recording catheter or electrode recording probe.

21 C.F.R. § 870.1220
in effectEffective: 2024-07-01
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(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).

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