📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K123311 ↗
Decision Date ?
January 14, 2013
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for percutaneous vascular access and catheter support within the vascular system.
- Intended for use in accordance with the device-specific labeling and applicable endovascular procedures.
Clinical Applications
- Supporting catheter navigation during percutaneous vascular procedures.
- Providing access support during endovascular treatment of venous disease when consistent with the product labeling.
- Facilitating catheter positioning in the venous circulation.
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.
Practical Considerations
- The available FDA summary does not specify the catheter's diameter range, working length, tip configuration, or compatible guidewire sizes; clinicians should consult the current instructions for use.
- Access is typically obtained through a percutaneous venous or arterial puncture, depending on the planned procedure, with fluoroscopic or other appropriate imaging guidance.
- Compatibility with sheaths, guidewires, contrast media, stents, and other catheters must be confirmed before use.
- MRI safety and conditional-use information are not provided in the supplied FDA record; check the device labeling before MRI.
- As with other intravascular catheters, potential complications include bleeding, infection, vessel injury, thrombosis, embolization, perforation, and contrast-related reactions.
Procedures that use this device
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.