

# QYI · Ablation Catheter, Renal Denervation

_ ·  · Class 3_

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

## Overview

- **Product Code:** QYI
- **Device Name:** Ablation Catheter, Renal Denervation
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

For denervating the renal nerves to lower blood pressure

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P220026](https://fda.innolitics.com/submissions/CV/CV-misc/QYI/P220026.md) | Symplicity Spyral Renal Denervation System | Medtronic, Inc. | Nov 17, 2023 | APPR |
| [P220023](https://fda.innolitics.com/submissions/CV/CV-misc/QYI/P220023.md) | Paradise® Ultrasound Renal Denervation System | Recor Medical, Inc. | Nov 7, 2023 | APPR |

## Top Applicants

- Medtronic, Inc. — 1 clearance
- Recor Medical, Inc. — 1 clearance

---

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

**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
