Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K233909Substantially Equivalent

Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister

Argon Medical Devices, Inc, Athens TX / Traditional, Substantially Equivalent

K233909 is the FDA 510(k) clearance record for Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister, a class II device, cleared for Argon Medical Devices, Inc. on under FDA product code QEW (Peripheral Mechanical Thrombectomy With Aspiration). FDA's definition for product code QEW reads: "To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration". FDA records list 64 510(k) clearances for Argon Medical Devices, Inc., from to . As of , FDA records show no recalls naming K233909.

Clearance record

Decision date
Received
(107 days to decision)
Product code
QEW Peripheral Mechanical Thrombectomy With Aspiration
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Argon Medical Devices, Inc. 1445 Flat Creek Rd., Athens TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEW

Trailing 12 months
11 clearances under product code QEW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEW, trailing twelve months
MonthClearances
November 20251
December 20251
January 20262
February 20262
March 20260
April 20261
May 20260
June 20260
July 20260
August 20262
September 20262
October 20260