U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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All TitlesTitle 21Chapter IPart 880Subpart F - Subpart F—General Hospital and Personal Use Therapeutic Devices
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(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).
