21 CFR 870.1200 - Diagnostic intravascular catheter.

Regulations last checked for updates: Feb 16, 2025

Title 21 - Food and Drugs last revised: Feb 03, 2025

View all text of Subpart B [§ 870.1025 - § 870.1915]

§ 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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

cite as: 21 CFR 870.1200