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) → NUI — Ultrasound, Infusion, System

# NUI · Ultrasound, Infusion, System

_Cardiovascular · 21 CFR 870.1200 · Class 2_

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

## Overview

- **Product Code:** NUI
- **Device Name:** Ultrasound, Infusion, System
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K062508](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NUI/K062508.md) | NEUROWAVE MICRO-INFUSION SYSTEM | Ekos Corp. | Dec 5, 2006 | SESU |
| [K053437](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NUI/K053437.md) | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | Jan 6, 2006 | SESE |
| [K051225](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NUI/K051225.md) | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | Jun 10, 2005 | SESU |
| [K041826](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NUI/K041826.md) | EKOS ULTRASOUND INFUSION SYSTEM | Ekos Corp. | Apr 27, 2005 | SESU |

## Top Applicants

- Ekos Corp. — 4 clearances

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

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