21 CFR 870.1220
§ 870.1220 Electrode recording catheter or electrode recording probe.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.1220, § 870.1220 Electrode recording catheter or electrode recording probe, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89876
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.