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watchman trusteer access system m635tu90050
Boston Scientific
Summary: The Watchman Trusteer Access System is a venous stent system used primarily in interventional cardiology and vascular surgery to treat venous obstructions. It is designed for use by healthcare professionals specializing in these fields.
FDA Clearance Information
Pathway
510K
Number
K240018 ↗
Decision Date
February 1, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Watchman Trusteer Access System, manufactured by Boston Scientific, received FDA clearance through the 510k pathway on February 1, 2024. It is classified as a Class 2 device under product code DQY.
What It Is
The Watchman Trusteer Access System is a medical device designed to facilitate the placement of venous stents. It is used to manage venous obstructions by providing a scaffold that helps maintain vessel patency. The system is engineered to be compatible with various stent sizes and configurations, making it versatile for different anatomical challenges.
Clinical Applications
This device is commonly used in procedures involving the treatment of venous stenosis or occlusions, particularly in the lower extremities. It is frequently employed in interventional cardiology and vascular surgery settings. The device is suitable for adult patients who present with symptomatic venous obstruction and require stenting to restore adequate blood flow.
Indications for Use
The FDA-cleared indications for the Watchman Trusteer Access System involve treating patients with venous obstructions. It is specifically indicated for use in individuals who need stent placement to alleviate symptoms associated with narrowed or blocked veins.
Practical Considerations
The Watchman Trusteer Access System is available in multiple sizes to accommodate different patient anatomies. It is important to ensure compatibility with existing stents and catheters. Clinicians should be familiar with the deployment technique to optimize outcomes and minimize complications.
Frequently Asked Questions
What is Watchman Trusteer Access System used for?
It is used for placing venous stents to treat venous obstructions.
What specialties typically use this device?
Interventional cardiology and vascular surgery specialists commonly use this device.
What are the FDA-cleared indications?
It is indicated for treating venous obstructions requiring stent placement to alleviate symptoms.
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.