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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

VStick Vascular Access Set

Manufacturer

Argon Medical Devices, Inc.

Date Cleared

2025-12-15

(21 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

K223791,K130730

Predicate For

N/A

Why did this record match?

Reference Devices :

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The V•Stick™ Vascular Access Set is intended for use in the introduction and placement of guidewires and/or catheters.

Device Description

The V•Stick™ Vascular Access Set consists of a 4F or 5F coaxial introducer set (with a 3F standard or 3F stiff dilator), a 21ga entry needle (with an echogenic or non-echogenic tip), and a 0.018" x 40cm Nitinol core and with Stainless Steel coil vascular access guidewire with an articulatable tip.

AI/ML Overview

N/A

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