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concierge guiding catheter
Merit Medical Systems
Summary: The Concierge 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 in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K132409 ↗
Decision Date
August 29, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Concierge Guiding Catheter was cleared through the FDA 510(k) pathway on August 29, 2013. It is manufactured by Merit Medical Systems and is classified as a Class 2 device under product code DQY.
What It Is
The Concierge Guiding Catheter is a specialized catheter designed to provide support and guidance for the placement of stents in venous systems. It features a flexible yet sturdy design that allows for precise navigation through the vascular system. The catheter's construction aids in minimizing trauma to the vessel walls while ensuring accurate delivery of therapeutic devices.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, particularly for patients requiring venous stenting. It is utilized in settings such as catheterization labs and hospitals, where precise vascular access and navigation are critical. The catheter is suitable for a wide range of patient populations, including those with venous obstructions or abnormalities.
Indications for Use
The FDA indications for the Concierge Guiding Catheter involve its use in procedures requiring the placement of venous stents. It is intended for patients who have conditions that necessitate the reinforcement or opening of venous pathways.
Practical Considerations
The Concierge Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of stents and other interventional devices. Clinicians should consider vessel size and access site when selecting the appropriate catheter size.
Frequently Asked Questions
What is the Concierge Guiding Catheter used for?
It is used to guide and support the placement of stents in venous procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring venous stenting to address obstructions or abnormalities in the venous system.
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.