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 Abbott Medical, Surgical Instrument Service and Savings, Inc. and Innovative Health, LLC.
FDA 510(k) Cleared Reprocessed Intravascular Ultrasound Catheter Devices (Product Code OWQ)
About Product Code OWQ - Regulatory Context
510(k) Submission Activity
30 total 510(k) submissions under product code OWQ since 2002, with 30 receiving FDA clearance (average review time: 173 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under OWQ have taken an average of 150 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.
OWQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →