FDA Product Code DYG: Catheter, Flow Directed
Leading manufacturers include Edwards Lifesciences and Edwards Lifesciences, LLC.
FDA 510(k) Cleared Catheter, Flow Directed Devices (Product Code DYG)
About Product Code DYG - Regulatory Context
510(k) Submission Activity
99 total 510(k) submissions under product code DYG since 1976, with 99 receiving FDA clearance (average review time: 107 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DYG have taken an average of 165 days to reach a decision - up from 105 days historically. Manufacturers should account for longer review timelines in current project planning.
DYG devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →