Cleared Traditional

K163051 - ClearLumen II Peripheral Thrombectomy S...

K163051 is an FDA 510(k) clearance for ClearLumen II Peripheral Thrombectomy S..., 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 112-day FDA review.

K163051 · Walk Vascular, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
112d
Days
Class 2
Risk

K163051 is an FDA 510(k) clearance for the ClearLumen II Peripheral 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 February 21, 2017 after a review of 112 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 - K163051

510(k) Number K163051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2016
Decision Date February 21, 2017
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 K163051.
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