21 CFR § 870.1230 Cardiovascular Devices

§ 870.1230 Fiberoptic oximeter catheter.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(a) Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

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

← § 870.1220 Electrode recording catheter or electrode recording probe.§ 870.1240 Flow-directed catheter. →