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intrakit
Medtronic Vascular
Summary: Intrakit is an embolization coil device used primarily in interventional radiology and vascular surgery to occlude blood vessels. It is typically used by specialists in these fields to treat conditions such as aneurysms or vascular malformations.
FDA Clearance Information
Pathway
510K
Number
K162097 ↗
Decision Date
November 17, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
Intrakit was cleared through the FDA 510(k) pathway on November 17, 2016. It is manufactured by Medtronic Vascular and classified as a Class 2 medical device under product code DYB.
What It Is
Intrakit is a medical device designed for embolization, which involves the deliberate occlusion of blood vessels. The device consists of coils that are deployed into the vasculature to block blood flow to specific areas, often to prevent bleeding or to treat aneurysms. The coils are delivered via a catheter and are designed to be flexible and conform to the vessel anatomy.
Clinical Applications
Intrakit is commonly used in procedures involving the occlusion of blood vessels, such as treating cerebral aneurysms or arteriovenous malformations. It is typically used in hospital settings by interventional radiologists or vascular surgeons. The device is suitable for a wide range of patient populations, including those with complex vascular conditions.
Indications for Use
Intrakit is indicated for use in patients who require embolization to occlude blood vessels. This can include patients with aneurysms, vascular malformations, or other conditions where blood flow needs to be controlled or stopped.
Practical Considerations
Intrakit comes in various sizes to accommodate different vessel diameters and anatomical locations. It is compatible with standard catheter systems used in interventional procedures. Clinicians should be familiar with the deployment technique to ensure proper placement and effectiveness.
Related Literature
The linked study investigated the variability in hypocretin measurement using a radioimmunoassay kit. It found that the shelf age of the kit influenced assay variability, while freezer time did not. The study involved 155 patient samples and showed high inter- and intra-assay correlation. However, it did not directly relate to the use of Intrakit.
Frequently Asked Questions
What is Intrakit used for?
Intrakit is used for embolization to occlude blood vessels, commonly in the treatment of aneurysms and vascular malformations.
What specialties typically use this device?
Intrakit is typically used by interventional radiologists and vascular surgeons.
What are the FDA-cleared indications?
Intrakit is cleared for embolization procedures to occlude blood vessels in patients with conditions like aneurysms or 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.