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cordis britecross support catheter
Cordis Us
Summary: The Cordis Britecross Support Catheter is used in venous stenting procedures. It is FDA 510k cleared and supported by 10 studies, focusing on its application in thrombectomy and catheter-based interventions.
FDA Clearance Information
Pathway
510K
Number
K233637 ↗
Decision Date
June 28, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis Britecross Support Catheter was cleared through the FDA 510k pathway on June 28, 2024. It is manufactured by Cordis Us and classified as a Class 2 medical device.
What It Is
The Cordis Britecross Support Catheter is a medical device designed to assist in venous stenting procedures. It provides support during catheter-based interventions, facilitating the delivery of therapeutic agents or devices to the target site.
Clinical Applications
This catheter is commonly used in procedures involving venous stents, particularly in the treatment of conditions like pulmonary embolism and intracranial stenosis. It aids in the precise placement and support of stents within the vasculature.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials and other study types, published between 2024 and 2025. These studies explore various catheter-based techniques and their outcomes.
Reported Outcomes
Published studies report that catheter-based interventions, including those using the Cordis Britecross Support Catheter, show potential for rapid symptom relief and hemodynamic stabilization in pulmonary embolism cases. However, there is a lack of randomized controlled trial data comparing different catheter-based interventions.
Safety Profile
Reported complications include the general risks associated with catheter-based procedures, such as vascular injury and bleeding. Specific safety data for the Cordis Britecross Support Catheter is limited in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of direct comparative studies on the efficacy of different catheter-based interventions. Further research is needed to establish long-term outcomes and safety profiles specific to the Cordis Britecross Support Catheter.
Frequently Asked Questions
What are the clinical indications for Cordis Britecross Support Catheter?
The Cordis Britecross Support Catheter is indicated for use in venous stenting procedures, particularly in conditions like pulmonary embolism and intracranial stenosis.
What outcomes have been reported in clinical studies?
Studies report potential benefits in symptom relief and hemodynamic stabilization in pulmonary embolism cases, though direct comparative data is limited.
What complications have been reported?
Reported complications include vascular injury and bleeding, common to catheter-based procedures, with limited specific safety data for this 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.