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 Medos International SARL, Merit Medical Systems, Inc. and Argon Medical Devices, Inc..
List of Catheter, Continuous Flush devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Continuous Flush devices (product code KRA). 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 →