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concentric balloon guide catheter model 90031
Concentric Medical
Summary: The Concentric Balloon Guide Catheter is a medical device used primarily in neurovascular procedures to assist in the placement of stents or other devices. It is typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K010954 ↗
Decision Date
October 9, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Concentric Balloon Guide Catheter, manufactured by Concentric Medical, was cleared through the FDA 510(k) pathway on October 9, 2001. It is a Class 2 device under product code DQY.
What It Is
The Concentric Balloon Guide Catheter is a specialized catheter designed to provide support and stability during endovascular procedures. It features a balloon near its tip that can be inflated to temporarily occlude blood flow, allowing for better control and precision when deploying other devices such as stents. This device is particularly useful in procedures that require precise navigation through the vascular system.
Clinical Applications
This catheter is commonly used in neurovascular interventions, such as the treatment of cerebral aneurysms or ischemic strokes. It is often employed in hospital settings, particularly in interventional radiology and neurosurgery departments. The device is suitable for adult patients who require endovascular treatment for conditions affecting the brain's blood vessels.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring vascular access and support, particularly in the placement of venous stents. It is intended for patients who need precise catheter guidance and stability during complex endovascular interventions.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with other endovascular devices and ensure appropriate sizing for the patient's vascular anatomy. Proper technique in inflating and deflating the balloon is crucial to avoid complications and ensure successful outcomes.
Frequently Asked Questions
What is the Concentric Balloon Guide Catheter used for?
It is used to provide support and stability during neurovascular procedures, such as stent placement in the brain.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access and support, particularly for venous stent placement.
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.