DeviceClearance

Product code OWQ— Cardiovascular

REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

Classification name
Reprocessed Intravascular Ultrasound Catheter
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Total cleared
31
First cleared
Most recent

FDA classification definition

“For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.”

— U.S. Food and Drug Administration, device classification record for product code OWQ under 21 CFR 870.1200, via openFDA

Market context for product code OWQ

FDA has cleared 31 devices under product code OWQ between 2002 and 2026, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OWQ

Recent clearances under product code OWQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.