Cleared Traditional

K233909 - Cleaner Plus 18F Thrombectomy System - ...

K233909 is the FDA 510(k) clearance for Cleaner Plus 18F Thrombectomy System - ... by Argon Medical Devices, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K233909 · Argon Medical Devices, Inc. · Cardiovascular device
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Mar 2024
Decision
107d
Days
Class 2
Risk

K233909 is an FDA 510(k) clearance for the Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter.... 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 March 28, 2024 after a review of 107 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

Submission Details

510(k) Number K233909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2023
Decision Date March 28, 2024
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 126
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K233909.
Indigo® Lightning Flash Aspiration System – Select +™ Catheter
K241399 · Penumbra, Inc. · Jun 2024
SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)
K241207 · Devoro Medical, Inc. · May 2024
ICE Aspiration System
K234073 · Expanse Medical, Inc. · Apr 2024
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