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 Evalve, Inc., Catheter Research C/O Burditt, Bowles & Radzius and Medtronic Cryocath, LP.