Cleared Traditional

K201998 - JETi AIO Peripheral Thrombectomy System

K201998 is an FDA 510(k) clearance for JETi AIO Peripheral 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 120-day FDA review.

K201998 · Walk Vascular, LLC · Cardiovascular device
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Nov 2020
Decision
120d
Days
Class 2
Risk

K201998 is an FDA 510(k) clearance for the JETi AIO 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 November 17, 2020 after a review of 120 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 - K201998

510(k) Number K201998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2020
Decision Date November 17, 2020
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 69
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K201998.
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
K212199 · Merit Medical Systems, Inc. · Nov 2021
Thrombuster II Aspiration Catheter
K213166 · Kaneka Medical America, LLC · Oct 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · AngioDynamics, Inc. · Jun 2021
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
K200871 · Control Medical Technology · May 2020
QuickClear Mechanical Thrombectomy System
K193197 · Volcano Atheromed, Inc. · Apr 2020
JETi Peripheral Thrombectomy System
K192439 · Walk Vascular, LLC · Dec 2019