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vascon polaris guiding catheter
Vascon
Summary: The Vascon Polaris Guiding Catheter is a medical device used primarily in interventional cardiology and radiology to facilitate the placement of other devices in the vascular system. It is typically used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K033633 ↗
Decision Date
February 18, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vascon Polaris Guiding Catheter was cleared through the FDA 510(k) pathway on February 18, 2004. 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 flexible tube designed to guide and support the placement of interventional devices within the vascular system. It is typically used to navigate through blood vessels to reach the target area where treatment is needed. The catheter's design allows for precise control and stability during procedures, which is crucial for successful outcomes.
Clinical Applications
This guiding catheter is commonly used in procedures involving venous stents, such as in the treatment of venous occlusions or stenosis. It is frequently utilized in interventional cardiology and radiology settings, where precision and stability are essential. The device is suitable for adult patients requiring vascular interventions, especially those with complex vascular anatomies.
Indications for Use
The FDA-cleared indications suggest that the Vascon Polaris Guiding Catheter is intended for use in patients requiring the placement of venous stents. It is particularly useful in conditions where vascular access is challenging and precise device placement is critical.
Practical Considerations
The Vascon Polaris Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of interventional devices and should be used by trained professionals familiar with vascular interventions. Proper technique and handling are essential to minimize complications.
Frequently Asked Questions
What is the Vascon Polaris Guiding Catheter used for?
It is used to guide and support the placement of interventional devices within the vascular system, particularly during procedures involving venous stents.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The catheter is indicated for use in patients requiring the placement of venous stents, especially in cases of venous occlusions 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.