FDA Product Code DYB: Introducer, Catheter
Safe vascular access is the first step in virtually every catheter-based cardiovascular procedure. FDA product code DYB covers catheter introducers — sheath-based systems that provide a stable access port into blood vessels.
These devices allow clinicians to introduce and exchange diagnostic and therapeutic catheters without repeated vessel puncture. They are used in cardiac catheterization, electrophysiology, TAVR, and peripheral vascular interventions.
DYB devices are Class II medical devices, regulated under 21 CFR 870.1340 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include CenterPoint Systems, LLC, Argon Medical Devices, Inc. and Abbott Medical.
FDA 510(k) Cleared Introducer, Catheter Devices (Product Code DYB)
About Product Code DYB - Regulatory Context
510(k) Submission Activity
701 total 510(k) submissions under product code DYB since 1977, with 701 receiving FDA clearance (average review time: 110 days).
Submission volume has increased in recent years - 40 submissions in the last 24 months compared to 25 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DYB have taken an average of 67 days to reach a decision - down from 113 days historically, suggesting improved FDA processing for this classification.
DYB devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →