Cleared Traditional

K211798 - Cleaner Plus Thrombectomy System

K211798 is an FDA 510(k) clearance for Cleaner Plus 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 259-day FDA review.

K211798 · Argon Medical Devices, Inc. · Cardiovascular device
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Feb 2022
Decision
259d
Days
Class 2
Risk

K211798 is an FDA 510(k) clearance for the Cleaner Plus 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 February 24, 2022 after a review of 259 days - an extended review cycle.

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 - K211798

510(k) Number K211798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2021
Decision Date February 24, 2022
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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 K211798.
Prodigy Thrombectomy System
K214114 · Truvic Medical, Inc. · Apr 2022
Artix Thrombectomy Device
K220600 · Inari Medical · Mar 2022
Pounce Thrombectomy System
K220501 · Surmodics,Inc. · Mar 2022
WOLF Thrombectomy System, 14F
K210911 · Devoro Medical, Inc. · Oct 2021
ClotTriever Thrombectomy System
K212632 · Inari Medical, Inc. · Oct 2021
WOLF Thrombectomy System, 6F
K210530 · Devoro Medical, Inc. · Aug 2021