{"data":{"id":"us/21-cfr-870.3945","jurisdiction":"us","citation":"21 CFR 870.3945","heading":"Prosthetic heart valve sizer.","body":"(a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.","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":"56742f7b824ee5a51d2eda1d157d455faa85cd5b14dd9e025eb61d11acceba11","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.3935","next":"us/21-cfr-870.4075"},"notice":"GroundRules: Original legal text. Not legal advice."}