21 CFR § 880.5200 - Intravascular catheter.

---
identifier: "/us/cfr/t21/s880.5200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.5200 - Intravascular catheter."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.5200"
section_name: "Intravascular catheter."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 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).