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§ 880.5200 Intravascular catheter.

21 CFR 880.5200

Citation21 CFR 880.5200
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 880.5200 Intravascular catheter.

(a) Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

(b) Classification. Class II (performance standards).