FDA Product Code DRA: Catheter, Steerable
FDA product code DRA covers steerable catheters used in cardiac electrophysiology and structural heart procedures.
These catheters incorporate a deflectable tip controlled by a handle mechanism, allowing the operator to navigate complex cardiac anatomy and position the catheter precisely at target sites within the heart. They are used for electrophysiology mapping, ablation, and transeptal procedures.
DRA devices are Class II medical devices, regulated under 21 CFR 870.1280 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Acutus Medical, Inc., Boston Scientific Corporation and Kardium, Inc..
FDA 510(k) Cleared Catheter, Steerable Devices (Product Code DRA)
About Product Code DRA - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code DRA since 1984, with 41 receiving FDA clearance (average review time: 104 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
FDA review times for DRA submissions have been consistent, averaging 99 days recently vs 104 days historically.
DRA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →