FDA Product Code KRA: Catheter, Continuous Flush

FDA product code KRA covers continuous flush catheters used for hemodynamic pressure monitoring.

These catheters incorporate a slow continuous infusion mechanism that maintains line patency and prevents thrombus formation in arterial pressure monitoring lines and pulmonary artery catheters. They deliver a controlled flush rate of 3 mL/hour without requiring manual flushing.

KRA devices are Class II medical devices, regulated under 21 CFR 870.1210 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Boston Scientific Corp, Merit Medical Systems, Inc. and Edwards Lifesciences, LLC.