CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART B—Cardiovascular Diagnostic Devices (§870.1025 to §870.1915) > 870.1240—Flow-directed catheter.

870.1240—Flow-directed catheter.

(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).