ORD

Optical Coherence Tomography, Intravascular Catheter

Product code

ORD

Device name

Optical Coherence Tomography, Intravascular Catheter

Device class

Class 2

21 CFR

21 CFR 870.1200

Medical specialty

Cardiovascular

Marketing pathway

510(K)

FDA classification definition

For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.

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