FDA Product Code OWQ: Reprocessed Intravascular Ultrasound Catheter

FDA product code OWQ covers reprocessed intravascular ultrasound catheters cleared for intracardiac and intraluminal visualization after a validated reprocessing cycle.

IVUS catheters are expensive single-use devices. Reprocessing provides a cost-effective alternative subject to rigorous cleaning, sterilization, and functional performance validation to demonstrate equivalence to the original device.

OWQ devices are Class II medical devices, regulated under 21 CFR 870.1200 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Innovative Health, LLC, Abbott Medical and Vein 360, LLC.