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.

Summary

Medtronic Interventional Vascular's Liberant RX Aspiration Catheter is filed under product code QEZ (Aspiration Thrombectomy Catheter).

Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Medtronic Interventional Vascular filed from Danvers, Massachusetts. The record shows 157 calendar days from receipt to decision (November 17, 2025 to April 23, 2026).

Clearance details

Applicant: Medtronic Interventional Vascular, Inc.
Product code: Product 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

view all

K262864 — FLOWRUNNER Aspiration System2026-10-26
K254035 — Mayumi Thrombectomy System2026-09-03
K261105 — Powered Aventus Thrombectomy System2026-07-27
K262030 — Aventus Thrombectomy System2026-07-15
K254208 — FLOWRUNNER Aspiration System2026-03-20

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.