Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5150](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5150) → QEX — Coronary Mechanical Thrombectomy With Aspiration

# QEX · Coronary Mechanical Thrombectomy With Aspiration

_Cardiovascular · 21 CFR 870.5150 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEX

## Overview

- **Product Code:** QEX
- **Device Name:** Coronary Mechanical Thrombectomy With Aspiration
- **Regulation:** [21 CFR 870.5150](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5150)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253407](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEX/K253407.md) | NeVa PV Thrombectomy Device | Vesalio, Inc. | Nov 24, 2025 | SESU |
| [K171493](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEX/K171493.md) | MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. | Aug 10, 2017 | SESE |
| [K163618](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEX/K163618.md) | INDIGO Aspiration System | Penumbra, Inc. | May 24, 2017 | SESU |

## Top Applicants

- Capture Vascular, Inc. — 1 clearance
- Penumbra, Inc. — 1 clearance
- Vesalio, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEX](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/QEX)

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