FDA Product Code DRE: Dilator, Vessel, For Percutaneous Catheterization

FDA product code DRE covers vessel dilators for percutaneous catheterization.

These tapered, rigid dilators are used to progressively enlarge the tissue tract and vascular puncture site created by the initial needle, facilitating the introduction of larger sheaths and catheters. They are a standard component of the Seldinger technique used in all catheter-based vascular access procedures.

DRE devices are Class II medical devices, regulated under 21 CFR 870.1310 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Baylis Medical Company, Inc., Merit Medical Systems, Inc. and Cook Incorporated.