Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200) → OGZ — Catheter, Intravascular, Plaque Morphology Evaluation

# OGZ · Catheter, Intravascular, Plaque Morphology Evaluation

_Cardiovascular · 21 CFR 870.1200 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ

## Overview

- **Product Code:** OGZ
- **Device Name:** Catheter, Intravascular, Plaque Morphology Evaluation
- **Regulation:** [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241576](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K241576.md) | Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Infraredx, Inc. | Feb 26, 2025 | SESE |
| [K183599](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K183599.md) | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | Apr 12, 2019 | SESE |
| [K163345](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K163345.md) | TVC Imaging System, TVC Catheter | Infraredx, Inc. | Jun 21, 2017 | SESE |
| [K141682](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K141682.md) | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | Nov 24, 2014 | SESE |
| [K133897](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K133897.md) | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | Apr 23, 2014 | SESE |
| [K130719](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K130719.md) | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | Oct 17, 2013 | SESE |
| [K123108](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K123108.md) | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | Mar 15, 2013 | SESE |
| [K093993](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K093993.md) | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | Jun 30, 2010 | SESE |
| [K072932](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ/K072932.md) | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Infraredx, Inc. | Apr 25, 2008 | SESE |

## Top Applicants

- Infraredx, Inc. — 9 clearances

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OGZ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com