# NWX · Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

_ ·  · Class 3_

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

## Overview

- **Product Code:** NWX
- **Device Name:** Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P230026](https://fda.innolitics.com/submissions/CV/CV-misc/NWX/P230026.md) | Lacrosse NSE ALPHA Coronary Dilatation Catheter | Goodman Co., Ltd. | Jun 6, 2024 | APPR |
| [P200041](https://fda.innolitics.com/submissions/CV/CV-misc/NWX/P200041.md) | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Dec 21, 2021 | APPR |
| [P050018](https://fda.innolitics.com/submissions/CV/CV-misc/NWX/P050018.md) | ANGIOSCULPT SCORING BALLOON CATHETER | Spectranetics Corp. | Jan 8, 2007 | APPR |
| [P950020](https://fda.innolitics.com/submissions/CV/CV-misc/NWX/P950020.md) | FLEXATOME CUTTING BALLOON | Boston Scientific Corp | Apr 18, 2000 | APPR |

## Top Applicants

- Boston Scientific Corp — 1 clearance
- Goodman Co., Ltd. — 1 clearance
- OrbusNeich Medical (Shenzhen) Co., Ltd. — 1 clearance
- Spectranetics Corp. — 1 clearance

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

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