Cleared Traditional

JETi Hydrodynamic Thrombectomy System

K243549 · Abbott Medical · Cardiovascular
Apr 2025
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K243549 is an FDA 510(k) clearance for the JETi Hydrodynamic Thrombectomy System, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Abbott Medical (S,Mta Clara, US). The FDA issued a Cleared decision on April 4, 2025, 140 days after receiving the submission on November 15, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K243549 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code QEZ — Aspiration Thrombectomy Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.

Similar Devices — QEZ Aspiration Thrombectomy Catheter

All 89
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
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
K250013 · Control Medical Technology, Inc. / Dba Ventiv Scientific · Mar 2025
AlphaVac MMA F1885 System (H787253020)
K240397 · AngioDynamics, Inc. · Apr 2024