DeviceClearance

Product code OGZ— Cardiovascular

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

Classification name
Catheter, Intravascular, Plaque Morphology Evaluation
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Total cleared
9
First cleared
Most recent

FDA classification definition

“Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.”

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

Market context for product code OGZ

FDA has cleared 9 devices under product code OGZ between 2008 and 2025, filed by 1 applicant company. 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

Top applicants under product code OGZ

Recent clearances under product code OGZ

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