# MOU · Intravascular Radiation Delivery System

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/MOU

## Overview

- **Product Code:** MOU
- **Device Name:** Intravascular Radiation Delivery System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P000052](https://fda.innolitics.com/submissions/CV/CV-misc/MOU/P000052.md) | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | Guidant Corp. | Nov 2, 2001 | APWD |
| [P990036](https://fda.innolitics.com/submissions/CV/CV-misc/MOU/P990036.md) | CORDIS CHECKMATE(TM) SYSTEM | Cordis Corp. | Nov 3, 2000 | APWD |
| [P000018](https://fda.innolitics.com/submissions/CV/CV-misc/MOU/P000018.md) | BETA-CATH (TM) SYSTEM | Best Vascular, Inc. | Nov 3, 2000 | APPR |

## Top Applicants

- Best Vascular, Inc. — 1 clearance
- Cordis Corp. — 1 clearance
- Guidant Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/MOU](https://fda.innolitics.com/submissions/CV/CV-misc/MOU)

**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