21 C.F.R. § 870.5175 Septostomy catheter.
Title 21 - Food and Drugs
(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. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart F—Cardiovascular Therapeutic Devices
§ 870.5175 Septostomy catheter.