Cleared Traditional

K243549 - JETi Hydrodynamic Thrombectomy System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K243549 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
140d
Days
Class 2
Risk

K243549 is an FDA 510(k) clearance for the JETi Hydrodynamic Thrombectomy System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Abbott Medical (Santa Clara, US). The FDA issued a Cleared decision on April 4, 2025 after a review of 140 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 Abbott Medical devices

Submission Details

510(k) Number K243549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date April 04, 2025
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04370691 Completed Observational Industry-sponsored

JETi Lower Extremity Arterial Thrombosis

JET Enhanced Thrombectomy Intervention Registry - JETi Registry

129
Patients (actual)
30
Sites
Condition studied Arterial Thrombosis
Eligibility All sexes · 18 Years+
Sponsor Abbott Medical Devices (industry)
Started 2020-03-06 → Primary completion 2024-01-16 → Completed 2024-10-09
Primary outcome
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
View full study on ClinicalTrials.gov

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 91
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K243549.
Liberant™ RX Aspiration Catheter
K253589 · Medtronic Interventional Vascular, Inc. · Apr 2026
FLOWRUNNER Aspiration System
K254208 · Expanse Medical, Inc. · Mar 2026
Aventus Thrombectomy System
K253925 · Inquis Medical · Jan 2026
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · AngioDynamics, Inc. · Nov 2025
Vesalio Peripheral System
K251312 · Vesalio, Inc. · Oct 2025
FLOWRUNNER Aspiration System
K251488 · Expanse Medical, Inc. · Jul 2025