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Argon Medical Devices, Inc. FDA Approvals

0 new drug approvals and 14 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial510(k)Feb 23, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2026
CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister510(k)Feb 5, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Feb 5, 2026
VariFuse Adjustable Infusion Catheter510(k)Jan 20, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 20, 2026
VStick Vascular Access Set510(k)Dec 15, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Dec 15, 2025
Option ELITE Vena Cava Filter System (352506070E 352506100E)510(k)Sep 10, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 10, 2024
TLAB® Transvenous Liver Biopsy System (TF-18C)510(k)Aug 1, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 1, 2024
Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister510(k)Mar 28, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 28, 2024
Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister510(k)Jan 19, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 19, 2024
10F Sheath and Dilator Set510(k)Dec 8, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit510(k)Sep 7, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 7, 2023
Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister510(k)Apr 10, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 10, 2023
Cleaner Plus Thrombectomy System510(k)Feb 24, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 24, 2022
Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set510(k)Jan 15, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 15, 2021
Halo Single-Loop Microsnare Kit510(k)Jan 5, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 5, 2021

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