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 Cordis Corp., C.R. Bard, Inc. and Cook Incorporated.