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Electronic Code of Federal Regulations

e-CFR data is current as of February 20, 2020

Title 21Chapter ISubchapter HPart 870Subpart 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).

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