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.
List of Dilator, Vessel, For Percutaneous Catheterization devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Dilator, Vessel, For Percutaneous Catheterization devices (product code DRE). 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 →