{"data":{"id":"us/21-cfr-870.3935","jurisdiction":"us","citation":"21 CFR 870.3935","heading":"Prosthetic heart valve holder.","body":"(a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.\n(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.","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":"db5c763b95e0829c5c81778998b7b38ce95ecdbe877d664c4b839335e5198b29","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.3925","next":"us/21-cfr-870.3945"},"notice":"GroundRules: Original legal text. Not legal advice."}