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angiographic wedge press dual thermod infusion
Norton Performance Plastics
Summary: The angiographic wedge press dual thermod infusion device is used in interventional radiology for venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to manage venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K852914 ↗
Decision Date
September 25, 1985
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on September 25, 1985. Manufactured by Norton Performance Plastics, it is classified as a Class 2 medical device under product code DQY.
What It Is
The angiographic wedge press dual thermod infusion device is designed to assist in the placement and management of venous stents. It operates by providing precise control over the infusion of contrast media, allowing for enhanced visualization during angiographic procedures. This device is particularly useful in ensuring accurate stent placement and assessing venous patency.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, this device is employed during procedures addressing venous obstructions, such as in cases of deep vein thrombosis or chronic venous insufficiency. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult patients requiring venous stenting.
Indications for Use
The device is indicated for use in patients with conditions requiring venous stenting, such as those with blocked or narrowed veins. It helps in the precise delivery and placement of stents to restore proper venous blood flow.
Practical Considerations
Clinicians should consider the compatibility of the device with existing catheter systems and ensure appropriate sizing for the target vein. Proper technique in handling and infusion is crucial to maximize the device's efficacy and safety.
Frequently Asked Questions
What is the angiographic wedge press dual thermod infusion used for?
It is used for the placement and management of venous stents, particularly in procedures requiring enhanced visualization and precise stent placement.
What specialties typically use this device?
Interventional radiologists and vascular surgeons primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for patients with venous obstructions or conditions requiring improved venous 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.