QEWClass II

Peripheral Mechanical Thrombectomy With Aspiration

21 CFR 870.5150 / Cardiovascular

QEW is the FDA product code for Peripheral Mechanical Thrombectomy With Aspiration, a class II device type, regulated under 21 CFR 870.5150. FDA's definition for this code reads: "To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration". As of 2026-09-10, FDA records hold 143 510(k) clearances under this code, the most recent dated 2026-08-21, and 10 recalls.

Classification record

Product code: QEW
Device name: Peripheral Mechanical Thrombectomy With Aspiration
FDA definition: To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Regulation: 21 CFR 870.5150
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 145
Ingested recalls: 10

Clearances, product code QEW

By decision year

145 clearances under product code QEW with a decision year between 2000 and 2026, 2023 the highest year at 23.

Show the numbers

510(k) clearances under FDA product code QEW by decision year
Year	Clearances
2000	1
2001	1
2002	1
2004	1
2005	1
2008	2
2009	2
2012	1
2013	2
2014	2
2015	4
2016	4
2017	2
2018	14
2019	8
2020	16
2021	11
2022	12
2023	23
2024	14
2025	14
2026	9

Applicants with the most clearances

Product code QEW

Applicants holding the most 510(k) clearances under product code QEW
Applicant	Clearances
Inari Medical, Inc.	47
Penumbra Inc.	26
Devoro Medical, Inc.	5
Inquis Medical, Inc.	5
Surmodics, Inc.	5
Vascular Medcure, Inc.	5
Argon Medical Devices, Inc	4
Contego Medical, Inc	4
Boston Scientific Corporation	2
C.R. Bard Inc	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order