đź“‹ FDA Reference
cordis obturator
Cordis
Summary: The Cordis Obturator is a medical device used in embolization procedures. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate the placement of embolization coils in blood vessels.
FDA Clearance Information
Pathway
510K
Number
K914352 ↗
Decision Date
November 22, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Obturator was cleared through the FDA 510(k) pathway on November 22, 1991. Manufactured by Cordis, it is classified as a Class 2 device under product code DYB.
What It Is
The Cordis Obturator is a specialized tool designed to assist in the placement of embolization coils within blood vessels. It functions as a guide, ensuring accurate delivery of coils to the target site. The device is typically used in minimally invasive procedures to treat vascular abnormalities by occluding blood flow to specific areas.
Clinical Applications
The Cordis Obturator is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures such as treating aneurysms or arteriovenous malformations by delivering embolization coils to the affected vessels. The device is suitable for adult and pediatric patients requiring vascular occlusion.
Indications for Use
The FDA-cleared indications for the Cordis Obturator involve its use in embolization procedures. It is intended for patients who need vascular occlusion to manage conditions like aneurysms or abnormal blood vessel formations.
Practical Considerations
When using the Cordis Obturator, clinicians should consider the compatibility with various embolization coils and catheters. The device is available in multiple sizes to accommodate different vessel diameters, ensuring precise coil placement.
Frequently Asked Questions
What is Cordis Obturator used for?
The Cordis Obturator is used to facilitate the placement of embolization coils in blood vessels during vascular occlusion procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Cordis Obturator in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in conditions like aneurysms or arteriovenous malformations.
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.