21 CFR § 870.1200 Cardiovascular Devices

§ 870.1200 Diagnostic intravascular catheter.

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

⚠ 3 pending changes to Part 870

(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).

← § 870.1140 Venous blood pressure manometer.§ 870.1210 Continuous flush catheter. →