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) > 870.1800—Withdrawal-infusion pump.

870.1800—Withdrawal-infusion pump.

(a) Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.
(b) Classification. Class II (performance standards).