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trailblazer support catheter
Ev3
Summary: The Trailblazer Support Catheter by Ev3 is a medical device used primarily in vascular procedures to support the placement and navigation of other devices. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K092299 ↗
Decision Date
August 7, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Trailblazer Support Catheter was cleared through the FDA 510(k) pathway on August 7, 2009. Manufactured by Ev3, it is classified as a Class 2 device under product code DQY.
What It Is
The Trailblazer Support Catheter is a flexible, tube-like device designed to facilitate the delivery and placement of guidewires and other interventional devices within the vascular system. It provides support and stability during procedures, allowing for precise navigation through complex vascular anatomy. The catheter is typically used in minimally invasive procedures to access and treat vascular conditions.
Clinical Applications
This device is commonly used in endovascular procedures, such as angioplasty or stent placement, where precise navigation and support are critical. It is often employed in settings such as hospitals and specialized vascular centers, and is used by interventional radiologists and vascular surgeons. The catheter is suitable for adult patients requiring vascular intervention, particularly in the treatment of peripheral artery disease.
Indications for Use
The FDA indications suggest that the Trailblazer Support Catheter is intended for use in procedures involving the placement of venous stents. It is designed to assist in navigating and supporting other devices within the vascular system, particularly in cases where vascular access is challenging.
Practical Considerations
The Trailblazer Support Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of guidewires and other interventional devices. Clinicians should be familiar with the catheter's handling characteristics and ensure proper technique to maximize its effectiveness during procedures.
Frequently Asked Questions
What is the Trailblazer Support Catheter used for?
The Trailblazer Support Catheter is used to support the placement and navigation of guidewires and other devices during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents, providing support and navigation within the vascular system.
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.