FDA Product Code OGZ: Catheter, Intravascular, Plaque Morphology Evaluation
Catheter Used For Delivery Of A Sensing Modality To A Coronary Or Peripheral Artery Region For Determination Of Atherosclerotic Plaque Characteristics. For Examination Of Morphologic Features Of Coronary Or Peripheral Artery Lesions Or Plaques.
Leading manufacturers include Infraredx, Inc..
FDA 510(k) Cleared Catheter, Intravascular, Plaque Morphology Evaluation Devices (Product Code OGZ)
About Product Code OGZ - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code OGZ since 2008, with 9 receiving FDA clearance (average review time: 179 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OGZ have taken an average of 268 days to reach a decision - up from 168 days historically. Manufacturers should account for longer review timelines in current project planning.
OGZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →