{"data":{"id":"us/21-cfr-870.3470","jurisdiction":"us","citation":"21 CFR 870.3470","heading":"Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.","body":"(a) Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.\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 D—Cardiovascular Prosthetic 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":"b1fb7a2a8b1d20f2266417c8dedcb99676bfc1b42e91576384fe2bc5d7be2f86","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.3460","next":"us/21-cfr-870.3535"},"notice":"GroundRules: Original legal text. Not legal advice."}