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equaflow multivalve infusion catheter
Cook
Summary: The Equaflow Multivalve Infusion Catheter by Cook is a Class 2 medical device used primarily for embolization procedures. It is utilized by interventional radiologists and vascular surgeons to deliver embolic agents precisely.
FDA Clearance Information
Pathway
510K
Number
K123235 ↗
Decision Date
February 14, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Equaflow Multivalve Infusion Catheter was cleared through the FDA 510(k) pathway on February 14, 2013. Manufactured by Cook, it is classified as a Class 2 device under product code DYB.
What It Is
The Equaflow Multivalve Infusion Catheter is a specialized catheter designed to deliver embolic agents to specific vascular sites. It features multiple valves that allow for controlled infusion, enhancing precision during embolization procedures. This device is particularly useful in managing vascular abnormalities by occluding blood vessels with embolic materials.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Equaflow Multivalve Infusion Catheter is employed in procedures requiring precise embolization, such as treating arteriovenous malformations or hypervascular tumors. It is suitable for use in hospital settings, particularly in catheterization labs, and is designed for adult patients requiring targeted embolization.
Indications for Use
The FDA-cleared indications for this device involve its use in embolization procedures, where it helps in delivering embolic agents to occlude blood vessels. It is indicated for patients with conditions that benefit from targeted vascular occlusion.
Practical Considerations
The Equaflow Multivalve Infusion Catheter is available in various sizes to accommodate different vascular anatomies. It is compatible with standard embolic agents and requires careful technique to ensure proper valve function and precise agent delivery.
Frequently Asked Questions
What is the Equaflow Multivalve Infusion Catheter used for?
It is used for delivering embolic agents during embolization procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in patients with vascular abnormalities.
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.