

# MCX · Catheter, Coronary, Atherectomy

_ ·  · Class 3_

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

## Overview

- **Product Code:** MCX
- **Device Name:** Catheter, Coronary, Atherectomy
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P130005](https://fda.innolitics.com/submissions/CV/CV-misc/MCX/P130005.md) | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | Oct 21, 2013 | APPR |
| [P980037](https://fda.innolitics.com/submissions/CV/CV-misc/MCX/P980037.md) | ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER | Boston Scientific Corp | Mar 12, 1999 | APPR |
| [P900056](https://fda.innolitics.com/submissions/CV/CV-misc/MCX/P900056.md) | ROTABLATOR(R) | Boston Scientific Corp | May 28, 1993 | APPR |
| [P910019](https://fda.innolitics.com/submissions/CV/CV-misc/MCX/P910019.md) | IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) | Intensive Technology, Inc. | May 18, 1993 | APWD |
| [P890043](https://fda.innolitics.com/submissions/CV/CV-misc/MCX/P890043.md) | SIMPSON CORONARY ATHEROCATH(TM) | Abbott Vascular | Sep 14, 1990 | APWD |

## Top Applicants

- Boston Scientific Corp — 2 clearances
- Abbott Vascular — 1 clearance
- Cardiovascular Systems, Inc. — 1 clearance
- Intensive Technology, Inc. — 1 clearance

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

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