FDA Product Code OBJ: Catheter, Ultrasound, Intravascular

FDA product code OBJ covers intravascular ultrasound catheters used for intracardiac and intraluminal visualization.

These catheters incorporate a miniaturized ultrasound transducer at their tip that generates real-time cross-sectional images of blood vessel walls and cardiac structures from within the vessel lumen. They provide anatomical detail not visible on standard angiography and are used in coronary artery disease assessment and structural heart interventions.

OBJ devices are Class II medical devices, regulated under 21 CFR 870.1200 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Boston Scientific Corporation and Biosense Webster, Inc..