eCFR Reference Browser

---

title: "21 CFR §880.5200"

source: "https://www.ecfr.gov/current/title-21/section-880.5200"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "880"

part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"

subpart_code: "F"

subpart_subject: "General Hospital and Personal Use Therapeutic Devices"

section_number: "880.5200"

section_subject: "Intravascular catheter."

cfr_reference: "21 CFR 880.5200"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§880.5200 - Intravascular catheter.