đź“‹ FDA Reference
retracta detachable embolization coil
Cook
Summary: The Retracta Detachable Embolization Coil is a medical device used to occlude blood vessels in various embolization procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K123712 ↗
Decision Date
January 3, 2013
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Retracta Detachable Embolization Coil was cleared through the FDA 510(k) pathway on January 3, 2013. Manufactured by Cook, it is classified as a Class 2 device under product code KRD.
What It Is
The Retracta Detachable Embolization Coil is a device designed to occlude or block blood vessels. It consists of a coil that can be precisely placed and detached within the vascular system to achieve embolization. This device is used to treat conditions such as aneurysms or to reduce blood flow to certain areas, thereby preventing hemorrhage or controlling bleeding.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures requiring vascular occlusion. It is particularly useful in treating cerebral aneurysms, gastrointestinal bleeding, and pre-surgical tumor embolization. The coil is deployed in a controlled manner, making it suitable for delicate procedures in both inpatient and outpatient settings.
Indications for Use
The FDA indications for the Retracta Detachable Embolization Coil include use in patients requiring embolization to control bleeding or reduce blood flow to specific areas. It is suitable for conditions like aneurysms or vascular malformations.
Practical Considerations
The Retracta coil comes in various sizes to accommodate different vessel diameters and anatomical locations. It is compatible with standard microcatheters used in embolization procedures. Clinicians should be familiar with the detachment mechanism to ensure precise placement.
Frequently Asked Questions
What is the Retracta Detachable Embolization Coil used for?
It is used for occluding blood vessels in embolization procedures to treat aneurysms, control bleeding, or reduce blood flow to specific areas.
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 embolization to control bleeding or reduce blood flow in conditions like aneurysms and vascular 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.