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.
FDA 510(k) Cleared Dilator, Vessel, For Percutaneous Catheterization Devices (Product Code DRE)
About Product Code DRE - Regulatory Context
510(k) Submission Activity
104 total 510(k) submissions under product code DRE since 1976, with 104 receiving FDA clearance (average review time: 103 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under DRE have taken an average of 65 days to reach a decision - down from 104 days historically, suggesting improved FDA processing for this classification.
DRE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →