📋 FDA Reference
Xcess Guiding Catheter
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 ?
510(k)
Number ?
K180797 ↗
Decision Date ?
December 14, 2018
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Guiding other medical devices into the venous system during percutaneous vascular procedures.
Clinical Applications
- Providing a conduit for advancing compatible interventional devices through the veins.
- Supporting catheter-based treatment of venous obstruction when other devices are used.
- Facilitating device positioning during percutaneous venous interventions.
- Providing venous access and support in procedures performed in a catheterization or interventional radiology laboratory.
Practical Considerations
- The catheter is available in different sizes and configurations; the appropriate option depends on vessel size, anatomy, access route and the intended device.
- Confirm compatibility with guidewires, balloons, stents, thrombectomy systems and other devices before use.
- The catheter is typically inserted through a percutaneous venous access site and advanced under fluoroscopic or other appropriate imaging guidance.
- Use careful technique to reduce the risk of vessel injury, bleeding, thrombosis, infection, dissection or perforation.
- MRI safety depends on the specific catheter model and whether it remains in the patient; consult the current manufacturer labeling before MRI.
Procedures that use this device
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.