Cleared Traditional

JETi 88 Peripheral Thrombectomy System (K183403) - FDA 510(k) Clearance

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

K183403 · Walk Vascular, LLC · Cardiovascular device
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Apr 2019
Decision
131d
Days
Class 2
Risk

K183403 is an FDA 510(k) clearance for the JETi 88 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 April 17, 2019 after a review of 131 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

Submission Details

510(k) Number K183403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2018
Decision Date April 17, 2019
Days to Decision 131 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
6d slower than avg
Panel avg: 125d · This submission: 131d
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 Consultant

Paul Gasser
Paul Gasser

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 34
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K183403.
QuickClear Mechanical Thrombectomy System
K193197 · Volcano Atheromed, Inc. · Apr 2020
JETi Peripheral Thrombectomy System
K192439 · Walk Vascular, LLC · Dec 2019
Aspiron(TM) Aspiration Catheter
K190619 · Meril Life Sciences Private Limited · 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