{"data":{"id":"us/21-cfr-870.4400","jurisdiction":"us","citation":"21 CFR 870.4400","heading":"Cardiopulmonary bypass blood reservoir.","body":"(a) Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.\n(b) Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, 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 E—Cardiovascular Surgical 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":"ca51672060b818610b95dd0626d86a35b6ff57692a1e60922c3ebda868e0b9c3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.4390","next":"us/21-cfr-870.4410"},"notice":"GroundRules: Original legal text. Not legal advice."}