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xcess guiding catheter
Curatia Medical
Summary: The Xcess Guiding Catheter is a medical device used in vascular procedures to guide other instruments into the venous system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K180797 ↗
Decision Date
December 14, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Xcess Guiding Catheter was cleared through the FDA 510k pathway on December 14, 2018. Manufactured by Curatia Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Xcess Guiding Catheter is a flexible tube designed to navigate through the venous system, providing a conduit for other devices such as stents or balloons. It is constructed to offer optimal support and flexibility, allowing clinicians to access difficult-to-reach areas within the vasculature. Its design facilitates precise placement and stability during interventional procedures.
Clinical Applications
This catheter is commonly used in procedures involving venous stenting, particularly in cases of venous obstruction or thrombosis. Interventional radiologists and cardiologists use it in hospital settings, often in catheterization labs. It is suitable for adult patients who require venous interventions, including those with chronic venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA indications for the Xcess Guiding Catheter include its use in guiding other devices into the venous system. It is intended for patients who need venous stenting or other vascular interventions.
Practical Considerations
The Xcess Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of interventional devices, and clinicians should ensure proper technique to minimize complications such as vessel trauma.
Frequently Asked Questions
What is Xcess Guiding Catheter used for?
It is used to guide other medical devices into the venous system during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in guiding other devices into the venous system, particularly for venous stenting procedures.
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.