# Argon Medical Devices, Inc.

- Location (FDA's records): Athens, TX
- FDA decisions: 25 (2007–2026): 25 510(k) clearances
- Names in FDA's records: Argon Medical Devices, Inc. (20); Argon Medical Devices (5)
- Product codes: DYB (9), MMX (4), QEW (4), KRA (2), KNW (2), DTK (1), QEY (1), DQX (1), LJS (1)
- 510(k) review time since 2016: median 124 days, against 64 for FDA's reviews in the same codes and years (5 of 18 faster)
- Predicates its devices cite: 28 (6 its own); citations of its devices by later devices: 7 (6 its own)
- Recalls linked to its devices: 6 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook, Inc.: 4 (https://510kreport.com/company/cook)
- Rex Medical: 3 (https://510kreport.com/company/rex-medical)
- Microvena Corp.: 2 (https://510kreport.com/company/microvena)
- Medical Device Technologies, Inc.: 2 (https://510kreport.com/company/medical-device-technologies)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)
- Argon Medical Corp.: 1 (https://510kreport.com/company/argon-medical)
- Pharmaseal Div., Baxter Healthcare Corp.: 1 (https://510kreport.com/company/pharmaseal-div-baxter-healthcare)

## Firms that cite its devices most
- Endovascular Engineering: 1 (https://510kreport.com/company/endovascular-engineering)

## Its most-cited devices
- K211798: Cleaner Plus Thrombectomy System (2022), cited by 3
- K232679: Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister (2024), cited by 1
- K201489: Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set (2020), cited by 1
- K191758: Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (2019), cited by 1
- K202141: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set (2021), cited by 1

## Recent decisions
- K252795: 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 Coaxial (Feb 23, 2026)
- K260028: CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (Feb 5, 2026)
- K251318: VariFuse Adjustable Infusion Catheter (Jan 20, 2026)
- K253741: V•Stick™ Vascular Access Set (Dec 15, 2025)
- K242612: Option ELITE Vena Cava Filter System (352506070E 352506100E) (Sep 10, 2024)
- K241145: TLAB® Transvenous Liver Biopsy System (TF-18C) (Aug 1, 2024)
- K233909: Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister (Mar 28, 2024)
- K232679: Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister (Jan 19, 2024)

Source page: https://510kreport.com/company/argon-medical-devices
