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qxmedical access support catheter
Qxmedical
Summary: The qxmedical access support catheter is a device used in vascular access procedures, primarily for venous stents. Key evidence highlights its role in improving vascular access for hemodialysis patients.
FDA Clearance Information
Pathway
510K
Number
K123311 ↗
Decision Date
January 14, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The qxmedical access support catheter was cleared by the FDA via the 510(k) pathway on January 14, 2013. It is manufactured by Qxmedical and classified as a Class 2 device.
What It Is
The qxmedical access support catheter is designed to facilitate vascular access, particularly in procedures involving venous stents. It aids in the navigation and support of catheters within the vascular system, enhancing procedural efficiency.
Clinical Applications
Commonly used in hemodialysis patients, the device supports the creation and maintenance of vascular access. It is particularly relevant in scenarios requiring the placement of venous stents or other vascular interventions.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2023 and 2025. These studies focus on vascular access techniques and outcomes.
Reported Outcomes
Published studies report that the qxmedical access support catheter improves the reliability of vascular access in hemodialysis patients. It is associated with enhanced procedural success rates and reduced complications related to catheter placement.
Safety Profile
Reported complications include minor procedural risks such as bleeding and infection, which are consistent with vascular access interventions. No significant adverse events specific to the device were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to evaluate the long-term safety and efficacy of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for qxmedical access support catheter?
The device is indicated for use in vascular access procedures, particularly in the placement and support of venous stents for hemodialysis patients.
What outcomes have been reported in clinical studies?
Studies report improved vascular access reliability and procedural success rates in hemodialysis patients using the device.
What complications have been reported?
Safety data indicate minor risks such as bleeding and infection, with no significant adverse events directly attributed to the device.
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.