GroundRules
21 CFR 870.5175: Septostomy catheter.
Where this section sits in the code
- 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 F—Cardiovascular Therapeutic Devices
(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).
Collected 2026-08-27T02:24:47Z. Source file · JSON