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..
List of Catheter, Ultrasound, Intravascular devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Ultrasound, Intravascular devices (product code OBJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →