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xablecath support catheter
Xablecath
Summary: The Xablecath support catheter is a device used primarily in venous stenting procedures. It was FDA-cleared via the 510(k) pathway in 2017. Key evidence highlights its role in managing catheter-related complications.
FDA Clearance Information
Pathway
510K
Number
K170041 ↗
Decision Date
September 7, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Xablecath support catheter was cleared by the FDA through the 510(k) pathway on September 7, 2017. It is manufactured by Xablecath and is classified as a Class 2 device under product code DQY.
What It Is
The Xablecath support catheter is designed to facilitate the placement and support of venous stents. It is intended for use in vascular procedures to aid in the management of venous obstructions.
Clinical Applications
Common clinical scenarios for the Xablecath support catheter include its use in procedures requiring venous stenting, particularly in cases of venous obstructions or thrombosis. It provides support and guidance during stent placement.
Evidence Summary
The available literature includes 10 studies, encompassing various study designs such as RCTs and retrospective analyses. The studies span from 2024 to 2025, focusing on catheter-related thrombosis and management strategies.
Reported Outcomes
Published studies report mixed outcomes regarding the efficacy of the Xablecath support catheter in preventing catheter-related thrombosis. While some studies highlight its utility in reducing complications, others indicate variability due to study design and patient conditions.
Safety Profile
Reported complications include catheter-related thrombosis and infection. The evidence suggests that while the device is generally safe, there is a need for careful monitoring of patients to manage potential adverse events.
Evidence Limitations
The evidence base is limited by small sample sizes and heterogeneous study designs, which affect the generalizability of findings. Further research is needed to establish standardized protocols and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Xablecath support catheter?
The Xablecath support catheter is indicated for use in venous stenting procedures, particularly in managing venous obstructions and thrombosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported mixed outcomes, with some indicating reduced complications in catheter-related thrombosis, while others show variability due to study design.
What complications have been reported?
Safety data from evidence indicate complications such as catheter-related thrombosis and infection, necessitating careful patient monitoring.
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.