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cobe catheter w guidewire assembly kit
Cobe Laboratories
Summary: The Cobe Catheter with Guidewire Assembly Kit is a medical device used primarily in interventional radiology for embolization procedures. It is typically utilized by radiologists and vascular surgeons to manage vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K853100 ↗
Decision Date
September 25, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cobe Catheter with Guidewire Assembly Kit was cleared through the FDA 510(k) pathway on September 25, 1985. Manufactured by Cobe Laboratories, it is classified as a Class 2 device under product code DYB.
What It Is
The Cobe Catheter with Guidewire Assembly Kit is a medical device designed for use in vascular interventions. It consists of a catheter and guidewire, which facilitate the navigation and delivery of embolic materials within the vascular system. This device is crucial in procedures that require precise placement of embolization coils to occlude blood vessels and manage abnormal blood flow.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for embolization procedures. It is particularly useful in treating conditions such as arteriovenous malformations, aneurysms, and other vascular abnormalities. The device is typically employed in hospital settings, catering to adult and pediatric patients requiring minimally invasive vascular interventions.
Indications for Use
The FDA indications for this device include its use in embolization procedures to manage vascular conditions. It is intended for patients with conditions that require the occlusion of blood vessels to prevent abnormal blood flow or bleeding.
Practical Considerations
The Cobe Catheter with Guidewire Assembly Kit is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be familiar with catheterization techniques to optimize outcomes.
Frequently Asked Questions
What is the Cobe Catheter w Guidewire Assembly Kit used for?
It is used for embolization procedures to manage vascular conditions by occluding blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to manage conditions requiring vascular occlusion.
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.