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torqvue low profile delivery catheter
Aga Medical Corporation (Wholly Owned By St.Jude Medical Cor
Summary: The TorqVue Low Profile Delivery Catheter is a medical device used for the delivery of venous stents. It is primarily used by interventional radiologists and cardiologists in procedures involving venous access.
FDA Clearance Information
Pathway
510K
Number
K162228 ↗
Decision Date
September 9, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The TorqVue Low Profile Delivery Catheter was cleared via the FDA 510(k) pathway on September 9, 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 TorqVue Low Profile Delivery Catheter is a specialized catheter designed to facilitate the delivery of venous stents. It features a low-profile design that allows for easier navigation through the venous system. The catheter is engineered to provide precise control and placement of stents, which is critical in ensuring optimal patient outcomes.
Clinical Applications
This device is commonly used in interventional procedures where venous stenting is required, such as in cases of venous obstruction or insufficiency. It is typically utilized in hospital settings by interventional radiologists and cardiologists. The catheter is suitable for a wide range of patient populations, including those with complex vascular anatomies.
Indications for Use
The TorqVue Low Profile Delivery Catheter is indicated for use in the delivery of venous stents. It is particularly useful in patients who require stenting to address venous blockages or to support venous structures.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and stents used in venous interventions. Clinicians should be familiar with the catheter's handling characteristics to ensure precise stent placement.
Frequently Asked Questions
What is the TorqVue Low Profile Delivery Catheter used for?
It is used for the delivery of venous stents in interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for delivering venous stents, particularly in cases of venous obstruction or insufficiency.
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.