{"data":{"id":"us/21-cfr-868.5800","jurisdiction":"us","citation":"21 CFR 868.5800","heading":"Tracheostomy tube and tube cuff.","body":"(a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.\n(b) Classification. Class II.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 868—ANESTHESIOLOGY DEVICES","Subpart F—Therapeutic 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":"01ca5e1ca378ebc5fa01e4e73bd906ff60ed2f557798d590375ff30bbab41664","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.5795","next":"us/21-cfr-868.5810"},"notice":"GroundRules: Original legal text. Not legal advice."}