FDA Product Code DXE: Catheter, Embolectomy
Leading manufacturers include Edwards Lifesciences and Edwards Lifesciences, LLC.
FDA 510(k) Cleared Catheter, Embolectomy Devices (Product Code DXE)
About Product Code DXE - Regulatory Context
510(k) Submission Activity
74 total 510(k) submissions under product code DXE since 1976, with 74 receiving FDA clearance (average review time: 148 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for DXE submissions have been consistent, averaging 164 days recently vs 147 days historically.
DXE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →