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vstick vascular access set
Argon Medical Devices
Summary: The vstick vascular access set by Argon Medical Devices is designed for vascular access procedures. It is primarily used in scenarios requiring reliable vascular access, such as chemotherapy and dialysis. Key evidence highlights its role in improving dialysis adequacy.
FDA Clearance Information
Pathway
510K
Number
K253741 ↗
Decision Date
December 15, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The vstick vascular access set received FDA 510k clearance (K253741) on December 15, 2025. Manufactured by Argon Medical Devices, it is classified as a Class 2 device under product code DYB.
What It Is
The vstick vascular access set is a medical device used to establish vascular access. It is designed for use in procedures requiring reliable and efficient access to the vascular system, such as intravenous therapy and hemodialysis.
Clinical Applications
Common clinical scenarios for the vstick vascular access set include use in patients undergoing chemotherapy, hemodialysis, and other treatments requiring repeated vascular access. It is particularly relevant in settings where vascular access is critical for patient management.
Evidence Summary
The literature includes 10 studies ranging from randomized controlled trials to retrospective analyses, published between 2021 and 2024. These studies explore various aspects of vascular access, including device utilization and safety.
Reported Outcomes
Published studies report that the vstick vascular access set is effective in improving dialysis adequacy and facilitating vascular access in cancer patients. The device has been associated with enhanced procedural outcomes in hemodialysis and chemotherapy settings.
Safety Profile
Reported complications include technical and logistical variability in device insertion and removal, particularly in urgent settings. However, specific adverse events related to the device itself are not extensively detailed in the available literature.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy outcomes, as well as to explore device performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for vstick vascular access set?
The vstick vascular access set is indicated for use in procedures requiring reliable vascular access, such as chemotherapy and hemodialysis.
What outcomes have been reported in clinical studies?
Studies have reported improved dialysis adequacy and effective vascular access in cancer patients undergoing chemotherapy.
What complications have been reported?
Reported complications include variability in device insertion and removal procedures, especially in urgent clinical settings.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.