Cleared Traditional

K253589 - Liberant™ RX Aspiration Catheter

K253589 is an FDA 510(k) clearance for Liberant RX Aspiration Catheter, manufactured by Medtronic Interventional Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K253589 · Medtronic Interventional Vascular, Inc. · Cardiovascular device
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Apr 2026
Decision
157d
Days
Class 2
Risk

K253589 is an FDA 510(k) clearance for the Liberant™ RX Aspiration Catheter. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Medtronic Interventional Vascular, Inc. (Danvers, US). The FDA issued a Cleared decision on April 23, 2026 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Interventional Vascular, Inc. devices

FDA 510(k) Submission Details - K253589

510(k) Number K253589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date April 23, 2026
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 85
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K253589.
Powered Aventus Thrombectomy System™
K261105 · Inquis Medical · Jul 2026
Aventus Thrombectomy System
K262030 · Inquis Medical · Jul 2026
FLOWRUNNER Aspiration System
K254208 · Expanse Medical, Inc. · Mar 2026
Aventus Thrombectomy System
K253925 · Inquis Medical · Jan 2026
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · AngioDynamics, Inc. · Nov 2025
Vesalio Peripheral System
K251312 · Vesalio, Inc. · Oct 2025