Cleared Traditional

CLEARLUMEN THROMBECTOMY SYSTEM (K140296) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140296 · Walk Vascular, LLC · Cardiovascular device
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Dec 2014
Decision
299d
Days
Class 2
Risk

K140296 is an FDA 510(k) clearance for the CLEARLUMEN THROMBECTOMY SYSTEM. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Walk Vascular, LLC (Irvine, US). The FDA issued a Cleared decision on December 2, 2014 after a review of 299 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 Walk Vascular, LLC devices

Submission Details

510(k) Number K140296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 06, 2014
Decision Date December 02, 2014
Days to Decision 299 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 125d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K140296.
JETi 88 Peripheral Thrombectomy System
K183403 · Walk Vascular, LLC · Apr 2019
Octane Mechanical Thrombectomy System
K182232 · Vascular Solutions, Inc. · Sep 2018
Octane aspiration system
K173266 · Vascular Solutions, Inc. · Dec 2017
Merit ASAPLP Aspiration Catheter
K132155 · Merit Medical Systems, Inc. · Nov 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · Medtronic, Inc. · Jul 2013
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · Medtronic, Inc. · Jun 2012