GroundRules
21 CFR 870.1240: Flow-directed 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 B—Cardiovascular Diagnostic Devices
(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
(b) Classification. Class II (performance standards).
Collected 2026-08-27T02:24:47Z. Source file · JSON