V•Stick™ Vascular Access Set

by Argon Medical Devices, Inc.

510(k) K253741

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253741↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Special	NumberK253741	Date15 Dec 2025Cleared	StatusActive
European Union	CE/MDD EUDAMED	Number—	Date—	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number: K253741
FDA product code: DYB

Device class: Class II
Regulation: 21 CFR Part 870.1340
Advisory committee: Cardiovascular
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The V-Stick Vascular Access Set is a Vascular Access Device designed for percutaneous vascular access, facilitating the introduction of .035" and .038" guidewires into the vascular system via a small needle puncture. It includes a coaxial introducer set (4F or 5F, with a 3F standard or 3F stiff dilator), a 21-gauge entry needle (with echogenic or non-echogenic tip), and a 0.018" nitinol or stainless steel guidewire featuring a floppy radiopaque tip. This configuration minimizes puncture site and vessel trauma during access procedures.

The set is intended for use in interventional radiology, cardiology, or vascular surgery settings, where precise vascular access is required. Supplied as a sterile, single-use device, it adheres to FDA 510(k) clearance (K253741) and MDD compliance. The introducer sizes (4F or 5F) and needle options (echogenic/non-echogenic) accommodate various procedural needs, with storage and handling per manufacturer instructions to maintain sterility. No MRI safety classification is specified.

From the manufacturer

V-Stick™ Vascular Access Sets assist in gaining vascular access for the placement of .035" and .038" guidewires into the vascular system using small needle access to reduce puncture site and vessel trauma.

Source: argonmedical.com

V-Stick Vascular Access Set with Talwire We Are Here to Help For all comments, questions, and feedback about our products, contact us below. Please note: our response time is typically 48-72 hours.

Source: argonmedical.com