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uresil irrigation catheter
Uresil
Summary: The Uresil Irrigation Catheter is a medical device used for irrigation in various clinical settings, primarily by interventional radiologists and surgeons. It is FDA-cleared for specific indications related to venous interventions.
FDA Clearance Information
Pathway
510K
Number
K863564 ↗
Decision Date
October 10, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Uresil Irrigation Catheter was cleared through the FDA 510(k) pathway on October 10, 1986. It is manufactured by Uresil and classified as a Class 2 device under product code DQY.
What It Is
The Uresil Irrigation Catheter is designed to facilitate the irrigation of bodily cavities or vessels. It typically consists of a flexible tube that can be inserted into the body to deliver fluids. This device is particularly useful in procedures requiring the flushing of debris or clots from venous stents or other vascular structures.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Uresil Irrigation Catheter aids in procedures such as venous stent maintenance and post-operative care. It is often utilized in hospital settings, particularly in patients requiring vascular access maintenance or those with complex venous conditions. The device is suitable for adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA indications suggest that this catheter is intended for use in procedures requiring irrigation, particularly in the context of venous interventions. It is suitable for patients who need assistance with maintaining patency in venous stents or similar devices.
Practical Considerations
The Uresil Irrigation Catheter comes in various sizes to accommodate different anatomical needs and procedural requirements. It is compatible with standard irrigation solutions and can be used with other vascular access devices. Clinicians should ensure proper technique to avoid complications such as infection or vessel damage.
Frequently Asked Questions
What is the Uresil Irrigation Catheter used for?
It is used for irrigating bodily cavities or vessels, particularly in venous interventions to maintain patency and remove debris.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for irrigation in venous interventions, particularly for maintaining patency in venous stents.
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.