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) → QEW — Peripheral Mechanical Thrombectomy With Aspiration

# QEW · Peripheral Mechanical Thrombectomy With Aspiration

_Cardiovascular · 21 CFR 870.5150 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/QEW

## Overview

- **Product Code:** QEW
- **Device Name:** Peripheral 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 (20 of 141)

Showing 20 most recent of 141 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260599](/device/K260599.md) | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | Apr 24, 2026 | SESE |
| [K260028](/device/K260028.md) | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister | Argon Medical Devices, Inc. | Feb 5, 2026 | SESE |
| [K251949](/device/K251949.md) | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | Feb 5, 2026 | SESE |
| [K253730](/device/K253730.md) | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | Jan 21, 2026 | SESE |
| [K251207](/device/K251207.md) | Sangria™ Thrombectomy System | Avantec Vascular Corporation | Jan 7, 2026 | SESE |
| [K252956](/device/K252956.md) | Helo Thrombectomy System | Endovascular Engineering, Inc. | Dec 18, 2025 | SESE |
| [K251070](/device/K251070.md) | Akura Thrombectomy System | Akura Medical | Nov 25, 2025 | SESE |
| [K253323](/device/K253323.md) | Protrieve Sheath | Inari Medical | Oct 29, 2025 | SESE |
| [K251185](/device/K251185.md) | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | Oct 22, 2025 | SESE |
| [K252612](/device/K252612.md) | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra, Inc. | Oct 16, 2025 | SESE |
| [K252057](/device/K252057.md) | Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System | Imperative Care, Inc. | Aug 28, 2025 | SESE |
| [K251485](/device/K251485.md) | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | Jun 13, 2025 | SESE |
| [K251189](/device/K251189.md) | Aventus Thrombectomy System | Inquis Medical | Jun 13, 2025 | SESE |
| [K250787](/device/K250787.md) | Liberant Thrombectomy System | Medtronic, Ireland | Jun 11, 2025 | SESE |
| [K250775](/device/K250775.md) | Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System | Imperative Care, Inc. | May 14, 2025 | SESE |
| [K250421](/device/K250421.md) | InThrill™ Thrombectomy System | Inari Medical, Inc. | May 12, 2025 | SESE |
| [K250668](/device/K250668.md) | Aventus Thrombectomy System (IM-2100) | Inquis Medical | Mar 25, 2025 | SESE |
| [K250088](/device/K250088.md) | FlowTriever2 Catheter | Inari Medical, Inc. | Mar 13, 2025 | SESE |
| [K250202](/device/K250202.md) | Aventus Thrombectomy System | Inquis Medical | Feb 26, 2025 | SESE |
| [K241894](/device/K241894.md) | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | Oct 15, 2024 | SESE |

## Top Applicants

- Penumbra, Inc. — 26 clearances
- Inari Medical — 24 clearances
- Inari Medical, Inc. — 23 clearances
- Devoro Medical, Inc. — 5 clearances
- Inquis Medical — 5 clearances

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**Source:** [https://fda.innolitics.com/productcode/QEW](https://fda.innolitics.com/productcode/QEW)

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