21 CFR 870.1200
§ 870.1200 Diagnostic intravascular catheter.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.1200, § 870.1200 Diagnostic intravascular catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89874
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.