{"data":{"id":"us/21-cfr-870.4350","jurisdiction":"us","citation":"21 CFR 870.4350","heading":"Cardiopulmonary bypass oxygenator.","body":"(a) Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.\n(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”","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 E—Cardiovascular Surgical 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":"26fe2ebbac9de299828f17eff2e06192f5084c4802a9fcce30277dc35a2afacc","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.4340","next":"us/21-cfr-870.4360"},"notice":"GroundRules: Original legal text. Not legal advice."}