Cleared Traditional

K161786 - ClearLumen II Thrombectomy System

K161786 is an FDA 510(k) clearance for ClearLumen II Thrombectomy System, manufactured by Walk Vascular, LLC. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K161786 · Walk Vascular, LLC · Cardiovascular device
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Oct 2016
Decision
111d
Days
Class 2
Risk

K161786 is an FDA 510(k) clearance for the ClearLumen II 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 October 18, 2016 after a review of 111 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K161786

510(k) Number K161786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 29, 2016
Decision Date October 18, 2016
Days to Decision 111 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
14d faster than avg
Panel avg: 125d · This submission: 111d
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 70
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K161786.
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
REFLOW ASPIRATION CATHETER
K123482 · Volcano Corporation · Apr 2013