Cleared Traditional

K232679 - Cleaner™ Pro Thrombectomy System

Also marketed or referenced as:
Cleaner™ Pro Aspiration Catheter with Handpiece Cleaner™ Pro Aspiration Canister

K232679 is an FDA 510(k) clearance for Cleaner Pro Thrombectomy System, manufactured by Argon Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K232679 · Argon Medical Devices, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
140d
Days
Class 2
Risk

K232679 is an FDA 510(k) clearance for the Cleaner™ Pro Thrombectomy System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on January 19, 2024 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 Argon Medical Devices, Inc. devices

FDA 510(k) Submission Details - K232679

510(k) Number K232679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2023
Decision Date January 19, 2024
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. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral 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 - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 136
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K232679.
Aventus Thrombectomy System (IM-2001/IM-0002)
K240117 · Inquis Medical · Mar 2024
VenaCore Thrombectomy Catheter (46-101)
K234034 · Inari Medical, Inc. · Feb 2024
Indigo® Aspiration System - Lightning® Flash
K240030 · Penumbra, Inc. · Feb 2024
ClotTriever Sheath
K233815 · Inari Medical, Inc. · Dec 2023
Aventus Thrombectomy System
K232730 · Inquis Medical · Nov 2023
ICHOR 14F Embolectomy System
K230743 · Ichor · Sep 2023