đź“‹ FDA Reference
cordis peel-away insertion tool
Cordis
Summary: The Cordis Peel-Away Insertion Tool is a medical device used primarily by interventional radiologists and cardiologists for the placement of embolization coils. It facilitates the insertion of devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K910688 ↗
Decision Date
May 16, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Peel-Away Insertion Tool was cleared through the FDA 510(k) pathway on May 16, 1991. Manufactured by Cordis, it is classified as a Class 2 medical device under product code DYB.
What It Is
The Cordis Peel-Away Insertion Tool is designed to aid in the insertion of medical devices, such as embolization coils, into the vascular system. It features a sheath that can be peeled away once the device is in place, minimizing trauma to the vessel and allowing for precise placement. This tool is particularly useful in procedures requiring the introduction of devices into narrow or delicate vessels.
Clinical Applications
Commonly used in interventional radiology and cardiology, this tool is essential for procedures involving the placement of embolization coils to treat aneurysms or vascular malformations. It is typically used in hospital settings, particularly in catheterization labs or interventional suites, and is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA indications suggest that this tool is intended for use in procedures where embolization coils are deployed to treat conditions such as aneurysms or other vascular abnormalities. It is designed to facilitate the safe and effective placement of these coils within the vascular system.
Practical Considerations
The Cordis Peel-Away Insertion Tool is available in various sizes to accommodate different vessel diameters and device sizes. It is compatible with a range of embolization coils and is designed to minimize vessel trauma during insertion. Clinicians should be familiar with the peel-away technique to ensure optimal outcomes.
Frequently Asked Questions
What is the Cordis Peel-Away Insertion Tool used for?
It is used for the insertion of embolization coils into the vascular system, often in the treatment of aneurysms or vascular malformations.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular interventions.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of embolization coils to treat vascular conditions like aneurysms.
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.