21 CFR § 870.2870
Catheter tip pressure transducer
June 25, 2020
(a) Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.
(b) Classification. Class II (performance standards).