ORDClass II

Optical Coherence Tomography, Intravascular Catheter

21 CFR 870.1200 / Cardiovascular

ORD is the FDA product code for Optical Coherence Tomography, Intravascular Catheter, a class II device type, regulated under 21 CFR 870.1200. FDA's definition for this code reads: "For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: ORD
Device name: Optical Coherence Tomography, Intravascular Catheter
FDA definition: For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Regulation: 21 CFR 870.1200
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code ORD

FDA records hold no clearances under product code ORD.

Recent recalls

Product code ORD

FDA records show no recalls under product code ORD.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)