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vascon polaris guiding catheter
Vascon
Summary: The Vascon Polaris Guiding Catheter is a medical device used to facilitate the placement of stents in venous procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K043387 ↗
Decision Date
February 16, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vascon Polaris Guiding Catheter was cleared through the FDA 510k pathway on February 16, 2005. It is manufactured by Vascon and classified as a Class 2 device under product code DQY.
What It Is
The Vascon Polaris Guiding Catheter is a specialized catheter designed to assist in the placement of venous stents. It provides a stable and flexible pathway for other devices to reach target sites within the venous system. The catheter's design allows for precise navigation through the vascular system, minimizing trauma to vessel walls.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving venous stenting. It is particularly useful in treating conditions such as venous obstructions or stenosis. The catheter is used in hospital settings, often in catheterization labs, and is suitable for adult patients with venous access needs.
Indications for Use
The FDA-cleared indications for the Vascon Polaris Guiding Catheter include its use in facilitating the placement of stents within the venous system. It is intended for patients requiring venous intervention due to conditions like stenosis or blockage.
Practical Considerations
The Vascon Polaris Guiding Catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stenting equipment and requires careful handling to ensure optimal placement and minimize vessel trauma.
Frequently Asked Questions
What is the Vascon Polaris Guiding Catheter used for?
It is used to facilitate the placement of venous stents during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating venous stent placement in patients with venous obstructions or stenosis.
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.