{"data":{"id":"us/21-cfr-870.1220","jurisdiction":"us","citation":"21 CFR 870.1220","heading":"Electrode recording catheter or electrode recording probe.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 870—CARDIOVASCULAR DEVICES","Subpart B—Cardiovascular Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"0ef81d597961ea79cf621b89a223ff44ce7bd3741045e13a81ea24fa554de5b3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.1210","next":"us/21-cfr-870.1230"},"notice":"GroundRules: Original legal text. Not legal advice."}