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..
FDA 510(k) Cleared Catheter, Ultrasound, Intravascular Devices (Product Code OBJ)
About Product Code OBJ - Regulatory Context
510(k) Submission Activity
78 total 510(k) submissions under product code OBJ since 2003, with 78 receiving FDA clearance (average review time: 92 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for OBJ submissions have been consistent, averaging 95 days recently vs 91 days historically.
OBJ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →