VStick Vascular Access Set (K253741): 510(k) cleared Dec 15, 2025

VStick Vascular Access Set

Argon Medical Devices, Inc. · Dec 15, 2025 · K253741

FDA cleared the VStick Vascular Access Set from Argon Medical Devices, Inc. on Dec 15, 2025 under K253741, a special 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 24, 2025. The decision came 21 days later, inside the 90 FDA-day goal for a 510(k).

Argon Medical Devices, Inc. has 3 other decisions in the tracker over the last 12 months: 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), K260028 (CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister), K251318 (VariFuse Adjustable Infusion Catheter).

Questions & Answers

What did FDA clear under K253741?

K253741 is the FDA 510(k) for VStick Vascular Access Set, submitted by Argon Medical Devices, Inc.. FDA's decision date was Dec 15, 2025, under product code DYB (Introducer, Catheter).

Who makes the VStick Vascular Access Set?

Argon Medical Devices, Inc., based in Athens, TX, is the applicant of record for K253741.

How long did the K253741 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Dec 15, 2025, 21 days later.

← All decisions in December 2025