eCFR Reference Browser

---

title: "21 CFR §870.1220"

source: "https://www.ecfr.gov/current/title-21/section-870.1220"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "870"

part_subject: "CARDIOVASCULAR DEVICES"

subpart_code: "B"

subpart_subject: "Cardiovascular Diagnostic Devices"

section_number: "870.1220"

section_subject: "Electrode recording catheter or electrode recording probe."

cfr_reference: "21 CFR 870.1220"

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 electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

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

§870.1220 - Electrode recording catheter or electrode recording probe.