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retracta detachable embolization coil
Cook
Summary: The Retracta Detachable Embolization Coil is a medical device used to occlude blood vessels. It is primarily used by interventional radiologists and vascular surgeons in procedures requiring embolization.
FDA Clearance Information
Pathway
510K
Number
K151676 ↗
Decision Date
July 22, 2015
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Retracta Detachable Embolization Coil, manufactured by Cook, received FDA clearance through the 510(k) pathway on July 22, 2015. 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 blood vessels by promoting clot formation. It is inserted into the vasculature using a catheter and can be detached once positioned correctly. The coil's design allows it to conform to the vessel's shape, ensuring effective embolization.
Clinical Applications
This device is commonly used in procedures to treat aneurysms, arteriovenous malformations, and other vascular abnormalities. It is frequently utilized in interventional radiology and vascular surgery settings, particularly in hospitals and specialized clinics. The patient population includes those with vascular conditions that require targeted embolization to prevent hemorrhage or reduce blood flow to a specific area.
Indications for Use
The FDA indications for the Retracta Detachable Embolization Coil involve its use in embolizing blood vessels. This is typically for patients with conditions like aneurysms or vascular malformations where reducing blood flow can prevent complications.
Practical Considerations
The Retracta Coil comes in various sizes to accommodate different vessel diameters. It is compatible with standard microcatheters used in embolization procedures. Clinicians should be familiar with catheter navigation techniques to ensure precise placement of the coil.
Frequently Asked Questions
What is the Retracta Detachable Embolization Coil used for?
It is used to occlude blood vessels in order to treat aneurysms, arteriovenous malformations, and other vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for embolizing blood vessels to treat 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.