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v-stick vascular access set
Argon Medical
Summary: The v-stick vascular access set by Argon Medical is a device used for vascular access procedures. It is primarily used in scenarios requiring embolization coils. Key evidence highlights its application in cancer treatment and hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K130730 ↗
Decision Date
November 22, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The v-stick vascular access set received FDA clearance through the 510(k) pathway on November 22, 2013. It is manufactured by Argon Medical and classified as a Class 2 device.
What It Is
The v-stick vascular access set is designed for facilitating vascular access in clinical settings. It is used to introduce embolization coils and other devices into the vascular system, aiding in procedures such as chemotherapy and hemodialysis.
Clinical Applications
Commonly used in oncology for systemic anti-cancer therapies and in nephrology for hemodialysis, the v-stick vascular access set is integral to procedures requiring reliable vascular access. It is also utilized in vascular surgeries and interventions.
Evidence Summary
The available literature includes 9 studies, encompassing various study types such as RCTs, prospective, and retrospective studies. The studies span from 2021 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the v-stick vascular access set is effective in providing reliable vascular access for systemic therapies in cancer patients and hemodialysis. The device has been associated with improved procedural outcomes and patient satisfaction in these clinical settings.
Safety Profile
Reported complications include device-related infections and thrombosis, as noted in some studies. However, the overall safety profile is considered acceptable within the context of its intended use.
Evidence Limitations
The evidence base is limited by a lack of large-scale randomized controlled trials specifically focusing on the v-stick vascular access set. Further research is needed to explore long-term outcomes and comparative effectiveness with other vascular access devices.
Frequently Asked Questions
What are the clinical indications for v-stick vascular access set?
The device is indicated for use in procedures requiring vascular access, such as embolization in oncology and hemodialysis in nephrology.
What outcomes have been reported in clinical studies?
Studies have reported effective vascular access and improved procedural outcomes in cancer treatment and hemodialysis settings.
What complications have been reported?
Safety data indicate potential complications such as infections and thrombosis, though these are considered within acceptable limits for its use.
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.