đź“‹ FDA Reference
teleport xt microcatheter
Orbusneich Medical (Shenzhen)
Summary: The Teleport XT Microcatheter is a specialized device used in vascular procedures, particularly for venous stenting. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K231608 ↗
Decision Date
January 7, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Teleport XT Microcatheter, manufactured by Orbusneich Medical (Shenzhen), was cleared via the FDA 510(k) pathway on January 7, 2024. It is classified as a Class 2 device under product code DQY.
What It Is
The Teleport XT Microcatheter is a small, flexible catheter designed to navigate the vascular system, particularly for delivering stents in venous interventions. Its design allows for precise placement and deployment of stents in challenging anatomical regions. The microcatheter's flexibility and compatibility with various guidewires make it a valuable tool in complex vascular procedures.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, often in cases of venous insufficiency or obstruction. Interventional radiologists and vascular surgeons employ the Teleport XT Microcatheter in hospital settings, particularly in catheterization labs. It is suitable for adult patients with conditions requiring venous stenting, such as chronic venous disease or post-thrombotic syndrome.
Indications for Use
The FDA-cleared indications for the Teleport XT Microcatheter involve its use in procedures requiring the placement of venous stents. It is intended for patients with venous conditions that necessitate stenting to restore proper blood flow.
Practical Considerations
The Teleport XT Microcatheter is available in various sizes to accommodate different vascular anatomies. It is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with catheter navigation techniques to optimize its use in complex vascular pathways.
Frequently Asked Questions
What is the Teleport XT Microcatheter used for?
It is used for delivering venous stents in vascular procedures, particularly for treating venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital and catheterization lab settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, particularly in patients with conditions like chronic venous disease.
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.