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concierge guiding catheter
Merit Medical Systems
Summary: The Concierge Guiding Catheter is a medical device used to facilitate the delivery of interventional devices in vascular procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K121051 ↗
Decision Date
June 13, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Concierge Guiding Catheter by Merit Medical Systems was cleared through the FDA 510(k) process on June 13, 2012. It is a Class 2 device under product code DQY.
What It Is
The Concierge Guiding Catheter is a flexible, tube-like device designed to guide and support the placement of interventional devices within the vascular system. It is typically used in procedures requiring precise navigation through blood vessels, such as angioplasty or stent placement. The catheter's design allows for enhanced control and stability during complex vascular interventions.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures involving the coronary and peripheral vasculature. It is particularly useful in settings where precise device placement is critical, such as in the treatment of coronary artery disease or peripheral vascular disease. Patients who require stent placement or angioplasty are typical candidates for procedures utilizing this catheter.
Indications for Use
The FDA indications for the Concierge Guiding Catheter include its use in facilitating the delivery of interventional devices within the vascular system. It is intended for patients undergoing procedures like angioplasty or stent placement, where precise device navigation is necessary.
Practical Considerations
The Concierge Guiding Catheter comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of interventional devices and should be selected based on the specific requirements of the procedure. Clinicians should ensure proper technique to maintain catheter stability and minimize vessel trauma.
Frequently Asked Questions
What is the Concierge Guiding Catheter used for?
It is used to guide and support the placement of interventional devices in vascular procedures, such as angioplasty or stent placement.
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 facilitating the delivery of interventional devices within the vascular system, particularly in angioplasty and stent placement procedures.
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.