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concentric guide catheter models 90018 90020
Concentric Medical
Summary: The concentric guide catheter is a medical device used primarily in interventional radiology and cardiology for venous stenting procedures. It is utilized by healthcare professionals to facilitate the placement of stents in veins.
FDA Clearance Information
Pathway
510K
Number
K003085 ↗
Decision Date
March 7, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The concentric guide catheter models 90018 and 90020 were cleared through the FDA 510(k) pathway on March 7, 2001. Manufactured by Concentric Medical, these devices are classified as Class 2 under product code DQY.
What It Is
The concentric guide catheter is a flexible tube designed to provide a conduit for the delivery of stents and other devices into the venous system. It is typically used in minimally invasive procedures to navigate through the vascular system. The catheter's design allows for precise control and positioning within the veins, facilitating the deployment of stents to treat venous obstructions or other vascular conditions.
Clinical Applications
Clinically, the concentric guide catheter is used in procedures involving the placement of venous stents, often in settings such as interventional radiology suites or cardiac catheterization labs. It is commonly employed in patients with conditions like deep vein thrombosis or chronic venous insufficiency. Specialists such as interventional radiologists and cardiologists utilize this device to improve venous blood flow and alleviate symptoms associated with venous blockages.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring the placement of stents within the venous system. It is intended for patients who have venous obstructions or require vascular access for therapeutic interventions.
Practical Considerations
The concentric guide catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of stents and other interventional devices. Clinicians should be familiar with the catheter's handling characteristics and ensure proper technique during insertion and navigation to minimize complications.
Frequently Asked Questions
What is the concentric guide catheter used for?
The concentric guide catheter is used for facilitating the placement of venous stents during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures involving venous stenting.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of stents in the venous system to treat obstructions or for vascular access.
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.