đź“‹ FDA Reference
Concierge Guiding Catheter
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 ?
510(k)
Number ?
K121051 ↗
Decision Date ?
June 13, 2012
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitates the delivery of interventional devices within the vascular system.
- Provides catheter support and guidance during percutaneous vascular procedures.
Clinical Applications
- Supporting delivery of angioplasty devices during percutaneous vascular procedures.
- Supporting delivery of stents during percutaneous vascular procedures.
- Providing a pathway for interventional devices in coronary vascular procedures.
- Providing a pathway for interventional devices in peripheral vascular procedures.
Practical Considerations
- Select the catheter size, length, and configuration according to the target vessel, access route, and interventional device being delivered.
- Confirm compatibility with the guidewire, sheath, balloon, stent, or other device used in the procedure.
- Use fluoroscopic or other appropriate imaging guidance and maintain catheter stability to reduce the risk of vessel injury.
- Review the current manufacturer instructions for use for contraindications, warnings, pressure limits, handling, and flushing requirements.
- MRI safety depends on the specific catheter model and whether it is present in the patient; consult the current labeling before an MRI examination.
Procedures that use this device
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.