{"data":{"id":"us/21-cfr-870.5175","jurisdiction":"us","citation":"21 CFR 870.5175","heading":"Septostomy catheter.","body":"(a) Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.\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 F—Cardiovascular 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":"abb2c5e6929390eaa471eaa3977d8699853e86e5414e028bf6ac595b71566bf3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.5150","next":"us/21-cfr-870.5200"},"notice":"GroundRules: Original legal text. Not legal advice."}