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e-CFR data is current as of November 19, 2020

Title 21Chapter ISubchapter HPart 870Subpart B → §870.1220


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices


§870.1220   Electrode recording catheter or electrode recording probe.

(a) Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

(b) Classification. Class II (performance standards).

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