Powered Aventus Thrombectomy System— 510(k) K261105

Name: FDA 510(k) clearance K261105
Creator: U.S. Food and Drug Administration
Published: 2026-07-27

Substantially Equivalent

Inquis Medical

FDA 510(k) clearance K261105 for Powered Aventus Thrombectomy System, Substantially Equivalent on 2026-07-27. Applicant: Inquis Medical. Device class: 2.

Clearance details

Applicant: Inquis Medical
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2026-04-03
Decision date: 2026-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEZ

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K262030 — Aventus Thrombectomy System2026-07-15
K253589 — Liberant RX Aspiration Catheter2026-04-23
K254208 — FLOWRUNNER Aspiration System2026-03-20
K253925 — Aventus Thrombectomy System2026-01-15
K252509 — AlphaVac Multipurpose Mechanical Aspiration System F18852025-11-24

More clearances from Inquis Medical

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K260091 — Aventus Introducer Sheath2026-04-13
K251189 — Aventus Thrombectomy System2025-06-13
K250668 — Aventus Thrombectomy System (IM-2100)2025-03-25
K250202 — Aventus Thrombectomy System2025-02-26
K240426 — Aventus Clot Management System2024-05-14

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.