đź“‹ FDA Reference
amplatzer torqvue 45x45 delivery sheath
Aga Medical Corporation (Wholly Owned By St. Jude Medical
Summary: The Amplatzer TorqVue 45x45 Delivery Sheath is a medical device used for the delivery of venous stents. It is typically used by interventional cardiologists and radiologists in procedures involving venous access.
FDA Clearance Information
Pathway
510K
Number
K163000 ↗
Decision Date
December 23, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer TorqVue 45x45 Delivery Sheath was cleared through the FDA 510(k) pathway on December 23, 2016. It is manufactured by Aga Medical Corporation, a subsidiary of St. Jude Medical, and is classified as a Class 2 device.
What It Is
The Amplatzer TorqVue 45x45 Delivery Sheath is a specialized catheter system designed to facilitate the delivery of venous stents into the vascular system. It features a flexible, yet sturdy design that allows for precise navigation through the venous anatomy. This device is crucial for ensuring that stents are accurately positioned in the target area, minimizing the risk of complications during venous interventions.
Clinical Applications
This delivery sheath is commonly used in procedures requiring venous stent placement, such as in cases of venous obstruction or stenosis. Interventional cardiologists and radiologists often employ this device in hospital settings, particularly in catheterization labs. It is suitable for adult patients who require venous stenting due to conditions like deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The FDA indications for the Amplatzer TorqVue 45x45 Delivery Sheath involve its use in delivering venous stents. It is intended for patients who need stent placement to treat narrowed or blocked veins, helping to restore proper blood flow.
Practical Considerations
The Amplatzer TorqVue 45x45 Delivery Sheath is typically compatible with a range of stent sizes, making it versatile for various clinical scenarios. Clinicians should ensure proper sizing and compatibility with the stent being used. Familiarity with catheterization techniques is essential for optimal use.
Frequently Asked Questions
What is the Amplatzer TorqVue 45x45 Delivery Sheath used for?
It is used for the delivery and placement of venous stents in patients with venous obstructions or stenosis.
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?
It is indicated for use in delivering venous stents to treat narrowed or blocked veins, improving blood flow.
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.