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crossing support catheter
Tractus Vascular
Summary: The crossing support catheter by Tractus Vascular is a device used primarily in venous stenting procedures. Key evidence highlights its role in facilitating catheter-directed interventions.
FDA Clearance Information
Pathway
510K
Number
K183305 ↗
Decision Date
August 5, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The crossing support catheter was cleared via the FDA 510k pathway on August 5, 2019. It is manufactured by Tractus Vascular and classified as a Class 2 device.
What It Is
The crossing support catheter is designed to assist in the navigation and support of guidewires and other interventional devices during venous stenting procedures. It is intended for use in vascular interventions to improve procedural efficiency.
Clinical Applications
Commonly used in venous stenting procedures, the crossing support catheter aids in the placement and support of guidewires, particularly in complex vascular anatomies. It is utilized in both elective and emergency settings.
Evidence Summary
The literature includes 15 studies, encompassing various study designs such as RCTs and systematic reviews, published between 2021 and 2025. These studies explore catheter-related interventions and associated outcomes.
Reported Outcomes
Published studies report that the crossing support catheter effectively facilitates catheter-directed interventions, improving procedural success rates in venous stenting. It has been associated with enhanced navigation and support in complex vascular procedures.
Safety Profile
Reported complications include catheter-related infections and procedural complications, as highlighted in studies focusing on catheter-associated infections and interventions. These emphasize the importance of adherence to safety protocols.
Evidence Limitations
The current evidence is limited by a lack of large-scale RCTs specifically focused on the crossing support catheter. Further research is needed to explore long-term outcomes and comparative effectiveness against alternative devices.
Frequently Asked Questions
What are the clinical indications for crossing support catheter?
The crossing support catheter is indicated for use in venous stenting procedures to aid in the navigation and support of guidewires and interventional devices.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and effective facilitation of catheter-directed interventions in venous stenting.
What complications have been reported?
Safety data from evidence indicate catheter-related infections and procedural complications as potential risks.
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.