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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
510K
Number
K180986 ↗
Decision Date
May 15, 2018
Product Code
DQY
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.
Clinical Applications
Commonly used in procedures involving venous stents, the Xablecath support catheter is integral in managing conditions requiring enhanced venous access. It is utilized in settings where precise catheter manipulation and support are critical.
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.
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.