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amplatzer torqvue fx
Aga Medical
Summary: The Amplatzer TorqVue FX is a medical device used for the placement of venous stents. It is typically utilized by interventional cardiologists and radiologists in procedures involving venous access.
FDA Clearance Information
Pathway
510K
Number
K121611 ↗
Decision Date
August 23, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue FX was cleared through the FDA 510(k) pathway on August 23, 2012. Manufactured by Aga Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer TorqVue FX is a delivery system designed to facilitate the placement of stents within the venous system. It consists of a catheter and a delivery sheath that allows for precise positioning and deployment of stents. This device is crucial in procedures where maintaining venous patency is necessary, such as in cases of venous obstruction.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly for patients requiring venous stenting due to conditions like venous stenosis or occlusion. It is suitable for use in hospitals and specialized clinics where vascular interventions are performed. The typical patient population includes those with chronic venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA indications for the Amplatzer TorqVue FX involve its use in procedures requiring venous stenting. It is intended for patients who need support in maintaining open venous pathways, often due to blockages or narrowing of the veins.
Practical Considerations
Clinicians should consider the compatibility of the Amplatzer TorqVue FX with the specific stents being used. It is important to select the appropriate size based on the patient's venous anatomy. Familiarity with the delivery technique is essential for successful deployment and positioning.
Frequently Asked Questions
What is Amplatzer TorqVue FX used for?
The Amplatzer TorqVue FX is used for the delivery and placement of venous stents to maintain open venous pathways.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in procedures involving venous access and stenting.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, particularly 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.