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selectsite c304 deflectable catheter system models c304-s59 c304-l69 c304-xs59 c304-xl74
Medtronic Vascular
Summary: The SelectSite C304 Deflectable Catheter System is used in venous stenting procedures. It is typically utilized by interventional cardiologists and vascular surgeons to navigate through the venous system.
FDA Clearance Information
Pathway
510K
Number
K061416 ↗
Decision Date
October 25, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SelectSite C304 Catheter System, manufactured by Medtronic Vascular, was cleared through the FDA 510(k) pathway on October 25, 2006. It is a Class 2 medical device under product code DQY.
What It Is
The SelectSite C304 Deflectable Catheter System is a medical device designed to facilitate the placement of venous stents. It features a deflectable tip that allows for precise navigation and positioning within the venous system. This system is particularly useful in complex vascular procedures where flexibility and control are crucial.
Clinical Applications
This catheter system is commonly used in procedures involving the placement of stents within the venous system, such as in cases of venous obstruction or insufficiency. It is typically employed in hospital settings by interventional cardiologists and vascular surgeons. The device is suitable for adult patients requiring venous stenting, often due to conditions like deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The SelectSite C304 Catheter System is indicated for use in procedures requiring venous stenting. It is designed for patients who need stent placement to address venous blockages or to improve blood flow in compromised veins.
Practical Considerations
The catheter system comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard venous stents and requires careful handling to ensure optimal positioning. Clinicians should be familiar with catheter manipulation techniques to maximize the device's effectiveness.
Frequently Asked Questions
What is the SelectSite C304 Catheter System used for?
It is used for placing stents in the venous system to treat conditions like venous obstruction or insufficiency.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to address blockages or improve venous blood flow.
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.