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lemaitre tt tortuous tracker introducer catheter delivery system
Lemaitre Vascular
Summary: The LeMaitre TT Tortuous Tracker Introducer Catheter is a medical device used for the delivery of venous stents. It is primarily used by vascular surgeons and interventional radiologists in procedures involving complex venous anatomy.
FDA Clearance Information
Pathway
510K
Number
K081878 ↗
Decision Date
January 27, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The LeMaitre TT Tortuous Tracker Introducer Catheter was cleared through the FDA 510(k) pathway on January 27, 2009. Manufactured by LeMaitre Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The LeMaitre TT Tortuous Tracker Introducer Catheter is designed to facilitate the delivery of venous stents in patients with challenging venous anatomy. Its design allows for navigation through tortuous vascular pathways, providing a stable platform for stent deployment. This device is particularly useful in cases where traditional catheters may struggle to access the target site due to vessel curvature or other anatomical complexities.
Clinical Applications
This device is commonly used in vascular surgery and interventional radiology settings, particularly for patients requiring venous stenting in complex anatomical regions. It is suitable for use in hospitals and specialized clinics where procedures involving venous access and intervention are performed. Patients with conditions such as chronic venous insufficiency or post-thrombotic syndrome may benefit from procedures using this catheter.
Indications for Use
The FDA-cleared indications for this device involve its use in the delivery of venous stents, particularly in patients with tortuous or complex venous anatomy. It is intended for use in procedures where standard catheters may not provide adequate access or stability.
Practical Considerations
The LeMaitre TT Tortuous Tracker Introducer Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of stent types and sizes, and clinicians should be familiar with the specific technique for navigating tortuous vessels to ensure successful stent delivery.
Frequently Asked Questions
What is the LeMaitre TT Tortuous Tracker Introducer Catheter used for?
It is used for the delivery of venous stents in patients with complex or tortuous venous anatomy.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for the delivery of venous stents, particularly in patients with tortuous or complex venous anatomy.
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.