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microsheath xl catheters
Flowcardia
Summary: The Microsheath XL Catheters by Flowcardia are used for venous stenting procedures. They are typically utilized by interventional radiologists and cardiologists to facilitate access and delivery of stents in venous systems.
FDA Clearance Information
Pathway
510K
Number
K073289 ↗
Decision Date
January 11, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Microsheath XL Catheters were cleared through the FDA 510(k) pathway on January 11, 2008. Manufactured by Flowcardia, this Class 2 device falls under product code DQY.
What It Is
The Microsheath XL Catheters are specialized catheters designed to assist in the placement of stents within venous systems. These catheters provide a conduit for delivering stents to targeted areas, ensuring precise placement and support within the vein. The device is engineered to navigate the venous anatomy with flexibility and stability, facilitating minimally invasive procedures.
Clinical Applications
Microsheath XL Catheters are commonly used in interventional radiology and cardiology for procedures involving venous stenting. These catheters are particularly useful in treating conditions such as venous obstructions or stenosis. They are typically employed in hospital settings, catering to adult patients who require intervention to restore venous patency.
Indications for Use
The FDA-cleared indications for Microsheath XL Catheters involve their use in procedures requiring venous stenting. This includes patients with narrowed or blocked veins needing stent placement to improve blood flow and alleviate symptoms associated with venous insufficiency.
Practical Considerations
Clinicians should consider the catheter's compatibility with various stent sizes and types when planning procedures. The device's flexibility and length options allow for adaptability to different patient anatomies and procedural requirements. Proper technique in catheter handling and stent deployment is crucial for optimal outcomes.
Frequently Asked Questions
What is Microsheath XL Catheters used for?
Microsheath XL Catheters are used for facilitating the placement of stents in venous systems during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting to treat conditions like venous obstructions or stenosis.
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.