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amplatzer torqvue 45x45 delivery sheath amplatzer torqvue la1 delivery sheath amplatzer torqvue la2 selivery sheath
Aga Medical
Summary: The Amplatzer TorqVue delivery sheaths are used in the placement of venous stents, primarily by interventional cardiologists and radiologists. They facilitate the precise delivery of devices within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K120120 ↗
Decision Date
March 15, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue delivery sheaths were cleared through the FDA 510(k) pathway on March 15, 2012. Manufactured by Aga Medical, they are classified as Class II devices under product code DQY.
What It Is
The Amplatzer TorqVue delivery sheaths are specialized medical devices designed to assist in the delivery of stents within the venous system. These sheaths provide a conduit for guiding stents to the target site, ensuring accurate placement. Their design includes features that allow for flexibility and maneuverability within the vascular anatomy, which is crucial for successful stent deployment.
Clinical Applications
These delivery sheaths are commonly used in interventional cardiology and radiology for procedures involving the placement of venous stents. They are particularly useful in settings where precise stent placement is critical, such as in the treatment of venous obstructions or congenital heart defects. Patients who benefit from these procedures often include those with venous insufficiency or structural heart conditions.
Indications for Use
The FDA indications for the Amplatzer TorqVue delivery sheaths involve their use in the delivery of stents within the venous system. This means they are intended for patients requiring stent placement to address venous blockages or structural heart issues.
Practical Considerations
The Amplatzer TorqVue delivery sheaths come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with a range of stent types and sizes, making them versatile tools in interventional procedures. Clinicians should be familiar with the device's handling and deployment techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the Amplatzer TorqVue delivery sheath used for?
It is used for the delivery of venous stents, facilitating precise placement within the vascular system.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in delivering stents to treat venous blockages or structural heart conditions.
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.