FDA product code · Cardiovascular
Optical Coherence Tomography, Intravascular Catheter
0 FDA decisions. No recall names this code.
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of ORD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · ORD
FDA has decided no ORD device since 2007.
Median 510(k) review, days · ORD
Too few ORD 510(k)s in any year since 2007 to give a median.
Recalls per year · ORD
No recall names ORD since 2007.
Adverse event reports per year · ORD
4in 2021
MAUDE reports naming product code ORD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in ORD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 870.1200.