OGZ

Catheter, Intravascular, Plaque Morphology Evaluation

Product code

OGZ

Device name

Catheter, Intravascular, Plaque Morphology Evaluation

Device class

Class 2

21 CFR

21 CFR 870.1200

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-02-26.

1 summaries are archived here for direct download.