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e-CFR data is current as of August 6, 2020 |
Title 21 → Chapter I → Subchapter H → Part 870 → Subpart B → §870.1200 |
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices
§870.1200 Diagnostic intravascular catheter.
(a) Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
(b) Classification. Class II (performance standards).