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xtrak support catheter
Xtrak Medical
Summary: The Xtrak Support Catheter is a medical device used in vascular procedures to support the placement of venous stents. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K032660 ↗
Decision Date
October 29, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Xtrak Support Catheter was cleared through the FDA 510(k) pathway on October 29, 2003. It is manufactured by Xtrak Medical and classified as a Class 2 device under product code DQY.
What It Is
The Xtrak Support Catheter is a specialized catheter designed to facilitate the placement and support of venous stents. It provides stability and guidance during the stenting procedure, ensuring accurate delivery of the stent to the target site. The catheter's design allows for flexibility and ease of navigation through the vascular system, making it a valuable tool in endovascular interventions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in procedures involving the treatment of venous obstructions or insufficiencies. It is often employed in hospitals and specialized vascular centers, where patients with conditions such as deep vein thrombosis or chronic venous insufficiency may require stenting. The catheter aids in precise stent placement, improving patient outcomes in these complex procedures.
Indications for Use
The FDA indications for the Xtrak Support Catheter involve its use in procedures requiring venous stenting. It is intended for patients with conditions that necessitate the reinforcement of venous structures, such as those with narrowed or blocked veins.
Practical Considerations
The Xtrak Support Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting equipment and requires careful handling to ensure optimal performance. Clinicians should be familiar with the catheter's specifications and technique considerations for successful use.
Frequently Asked Questions
What is the Xtrak Support Catheter used for?
The Xtrak Support Catheter is used to support the placement of venous stents in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, such as treating narrowed or blocked veins.
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.