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FDA 510(k)

V•Stick™ Vascular Access Set

K-Number: K253741 · 2025-12-15

ApplicantArgon Medical Devices, Inc.
Decision Date2025-12-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V•Stick™ Vascular Access Set is a medical device manufactured by Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2025-12-15 under approval number K253741. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V•Stick™ Vascular Access Set?

V•Stick™ Vascular Access Set is a medical device that received FDA 510(k) clearance on 2025-12-15. It is manufactured by Argon Medical Devices, Inc.. The 510(k) number is K253741.

When was V•Stick™ Vascular Access Set approved by the FDA?

V•Stick™ Vascular Access Set received FDA 510(k) clearance on 2025-12-15, under approval number K253741.

What company makes V•Stick™ Vascular Access Set?

V•Stick™ Vascular Access Set is manufactured by Argon Medical Devices, Inc..

What is the FDA product code for V•Stick™ Vascular Access Set?

The FDA product code for V•Stick™ Vascular Access Set is DYB.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT06904651 VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery ACTIVE_NOT_RECRUITING NCT07599085 Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures NOT_YET_RECRUITING NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04484220 Ellipsys Vascular Access System Post Market Surveillance (PS) Study COMPLETED

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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