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amplatzer reliant catheter delivery system
Aga Medical
Summary: The Amplatzer Reliant Catheter Delivery System is a medical device used primarily for the deployment of venous stents. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K070238 ↗
Decision Date
February 28, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer Reliant Catheter Delivery System was cleared through the FDA 510(k) pathway on February 28, 2007. Manufactured by Aga Medical, it is a Class 2 device under product code DQY.
What It Is
The Amplatzer Reliant Catheter Delivery System is designed to facilitate the delivery and deployment of venous stents. It consists of a catheter that provides a pathway for stent placement within the venous system. This system is crucial for ensuring precise stent positioning, which is essential for maintaining venous patency and improving blood flow.
Clinical Applications
This device is commonly used in procedures involving venous stenting, particularly in cases of venous obstruction or insufficiency. Interventional cardiologists and vascular surgeons utilize this system in hospital settings, especially in catheterization labs. It is suitable for adult patients who require venous stenting to alleviate symptoms associated with venous diseases.
Indications for Use
The FDA-cleared indications for this device include the deployment of stents in the venous system. It is intended for patients with conditions such as venous obstruction or insufficiency that require stenting to restore proper blood flow.
Practical Considerations
The Amplatzer Reliant Catheter Delivery System is compatible with a range of stent sizes, allowing for flexibility in treating various venous conditions. Clinicians should be familiar with catheter navigation techniques to ensure accurate stent placement. Proper sizing and compatibility with the stent are crucial for optimal outcomes.
Frequently Asked Questions
What is the Amplatzer Reliant Catheter Delivery System used for?
It is used for the deployment of venous stents to treat conditions like venous obstruction or insufficiency.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the deployment of stents in the venous system to treat venous obstruction or insufficiency.
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.