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 Abbott Medical.
List of Catheter, Steerable devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Steerable devices (product code DRA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →