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amplatzer torq vue 2 delivery sheath model 9-tv2-05f120 model 9-tv2-06f120 modeltv-2-07f120
Aga Medical
Summary: The Amplatzer Torq Vue 2 Delivery Sheath is a medical device used for the delivery of venous stents. It is commonly utilized by interventional cardiologists and radiologists in procedures involving venous access.
FDA Clearance Information
Pathway
510K
Number
K093476 ↗
Decision Date
February 5, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer Torq Vue 2 Delivery Sheath, manufactured by Aga Medical, received FDA clearance via the 510(k) pathway on February 5, 2010. It is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer Torq Vue 2 Delivery Sheath is a specialized catheter system designed to facilitate the delivery of stents into the venous system. It features a flexible, torqueable design that allows for precise navigation through the vascular anatomy. The sheath is available in various sizes to accommodate different patient anatomies and procedural requirements.
Clinical Applications
This device is primarily used in interventional cardiology and radiology for procedures requiring venous stent placement. It is particularly useful in treating conditions such as venous obstructions or stenosis. The sheath is employed in both hospital and outpatient settings, catering to adult and pediatric patient populations.
Indications for Use
The FDA-cleared indications for the Amplatzer Torq Vue 2 Delivery Sheath include its use in delivering stents to treat venous conditions. It is intended for patients with venous blockages or narrowing that require stenting to restore proper blood flow.
Practical Considerations
The Amplatzer Torq Vue 2 Delivery Sheath comes in various sizes, typically ranging from 5F to 7F in diameter, to suit different procedural needs. It is compatible with a range of stents and should be selected based on the specific anatomical and procedural requirements. Clinicians should be familiar with the torqueable design to optimize navigation and placement.
Frequently Asked Questions
What is the Amplatzer Torq Vue 2 Delivery Sheath used for?
It is used for the delivery of venous stents to treat conditions like venous obstructions or stenosis.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for delivering stents in patients with venous blockages or narrowing.
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.