FDA product code OGZ: Catheter, Intravascular, Plaque Morphology Evaluation
OGZ is the FDA product code for catheter, intravascular, plaque morphology evaluation. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. FDA has cleared 9 510(k) submissions under OGZ, 1 in the last five years. The average 510(k) review took 179 days (median 188); 268 days on average over the last three years. FDA has posted 1 recall for OGZ devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intravascular, Plaque Morphology Evaluation |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 204 |
| 2019 | 1 | 107 |
| 2025 | 1 | 268 |
Compare with all 510(k) review times · Search every OGZ clearance
Top OGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Infraredx, Inc. | 9 | 2025-02-26 |
Most recent OGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241576 | Infraredx, Inc. | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | 2025-02-26 | 268 |
| K183599 | Infraredx, Inc. | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | 2019-04-12 | 107 |
| K163345 | Infraredx, Inc. | TVC Imaging System, TVC Catheter | 2017-06-21 | 204 |
| K141682 | Infraredx, Inc. | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | 2014-11-24 | 154 |
| K133897 | Infraredx, Inc. | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | 2014-04-23 | 124 |
Recalls for OGZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-12-15.
Frequently asked questions
What is FDA product code OGZ?
OGZ is the FDA product code for catheter, intravascular, plaque morphology evaluation. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.
What device class is OGZ?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code OGZ?
Across 9 cleared submissions the average was 179 days from receipt to decision (median 188).
Which companies have the most OGZ clearances?
Infraredx, Inc. (9).
Have OGZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code OGZ
- Run a recall and safety report across every OGZ manufacturer
- Watch product code OGZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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