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tractus crossing support catheter
Tractus Vascular
Summary: The Tractus Crossing Support Catheter is a medical device used to assist in the placement of venous stents. It is typically used by interventional radiologists and vascular surgeons in procedures involving the venous system.
FDA Clearance Information
Pathway
510K
Number
K180889 ↗
Decision Date
December 7, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Tractus Crossing Support Catheter was cleared through the FDA 510(k) pathway on December 7, 2018. It is manufactured by Tractus Vascular and classified as a Class 2 device under product code DQY.
What It Is
The Tractus Crossing Support Catheter is a specialized catheter designed to facilitate the crossing of lesions in the venous system, aiding in the placement of stents. It is constructed to provide support and stability during complex vascular procedures. The device's design allows it to navigate through challenging vascular anatomy, making it a valuable tool in interventional procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in procedures involving the placement of venous stents. It is utilized in hospitals and specialized vascular centers, often in patients with venous obstructions or other vascular conditions requiring stenting. The catheter assists in navigating through difficult lesions, ensuring precise stent placement.
Indications for Use
The FDA indications for the Tractus Crossing Support Catheter involve its use in facilitating the placement of venous stents. It is intended for patients with conditions that require stenting of the venous system, such as venous obstructions or strictures.
Practical Considerations
The Tractus Crossing Support Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with catheter manipulation techniques to optimize its use in complex vascular procedures.
Frequently Asked Questions
What is the Tractus Crossing Support Catheter used for?
It is used to assist in the placement of venous stents by providing support and stability during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of venous stents in patients with venous obstructions or strictures.
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.