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Xablecath Support Catheter Product Family
Xablecath
Summary: The Xablecath support catheter is designed for use in venous stent procedures. It is FDA-cleared and supported by 9 studies, focusing on its clinical application and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180986 ↗
Decision Date ?
May 15, 2018
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Xablecath support catheter received FDA clearance through the 510(k) pathway on May 15, 2018. It is manufactured by Xablecath and classified as a Class 2 device.
What It Is
The Xablecath support catheter is a medical device used in venous stent procedures. It aids in the placement and support of stents within the venous system, facilitating improved vascular access and treatment outcomes.
FDA-Cleared Indications
- Used percutaneously to provide catheter support and facilitate access during endovascular procedures.
- Cleared for use in procedures involving the vascular system when catheter support or positioning is required.
- The available FDA record identifies the device under product code DQY, Catheter, Percutaneous.
Clinical Applications
- Providing support during venous stent placement.
- Facilitating catheter and guidewire access through the venous system.
- Supporting manipulation and positioning of interventional devices during iliac or central venous procedures.
- Assisting endovascular treatment in situations where additional catheter support is needed.
Evidence Summary
The available literature includes 9 studies, encompassing various study types such as RCTs and case series. These studies span from 2016 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Xablecath support catheter demonstrates efficacy in facilitating venous stent placement, with improved procedural success rates. The device is noted for its role in enhancing catheter manipulation and support during complex procedures.
Safety Profile
Reported complications include typical catheter-related issues such as insertion site reactions and minor vascular trauma. Overall, the device has a favorable safety profile with no significant adverse events noted in the studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish the long-term safety and efficacy of the device in diverse patient populations.
Practical Considerations
- The appropriate catheter size, length, and compatibility depend on the access site, target vessel, guidewire, introducer sheath, and stent system.
- Use requires fluoroscopic or other appropriate imaging guidance and standard sterile endovascular technique.
- The catheter should be inspected before use and advanced without force to reduce the risk of vessel injury, dissection, perforation, or catheter damage.
- MRI safety and conditional use depend on the current device labeling and exact model; confirm the manufacturer’s MRI information before scanning.
- Contraindications, warnings, and compatibility requirements should be checked in the current instructions for use before the procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Xablecath support catheter?
The Xablecath support catheter is indicated for use in venous stent procedures, aiding in the placement and support of stents within the venous system.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and enhanced catheter manipulation during venous stent placement.
What complications have been reported?
Reported complications include insertion site reactions and minor vascular trauma, with an overall favorable safety profile.
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.