21 C.F.R. § 870.1200

Current through November 30, 2024
Section 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).

21 C.F.R. § 870.1200