Liberant RX Aspiration Catheter— 510(k) K253589

Name: FDA 510(k) clearance K253589
Creator: U.S. Food and Drug Administration
Published: 2026-04-23

Substantially Equivalent

Medtronic Interventional Vascular, Inc.

FDA 510(k) clearance K253589 for Liberant RX Aspiration Catheter, Substantially Equivalent on 2026-04-23. Applicant: Medtronic Interventional Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Interventional Vascular, Inc.
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2025-11-17
Decision date: 2026-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEZ

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K261105 — Powered Aventus Thrombectomy System2026-07-27
K262030 — Aventus Thrombectomy System2026-07-15
K254208 — FLOWRUNNER Aspiration System2026-03-20
K253925 — Aventus Thrombectomy System2026-01-15

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.