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desilet
Ex
Summary: Desilet is a clinician-facing device used primarily for embolization-coils. Key evidence findings include its FDA clearance and its application in various clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K813143 ↗
Decision Date
November 27, 1981
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
Desilet was cleared through the FDA 510k pathway on November 27, 1981, by manufacturer Ex. It is classified as a Class 2 device under product code DYB.
What It Is
Desilet is a medical device designed for use in embolization procedures, specifically involving coils. It is intended to aid in the occlusion of blood vessels, thereby preventing blood flow to certain areas.
Clinical Applications
Desilet is commonly used in interventional radiology and vascular surgery for the treatment of aneurysms and other vascular abnormalities. It provides a minimally invasive option for managing these conditions.
Evidence Summary
The available literature includes 9 studies, with a mix of RCTs, prospective, and retrospective studies. The studies span from 2010 to 2025, providing a broad view of the device's clinical applications.
Reported Outcomes
Published studies report varied outcomes related to the use of desilet in embolization procedures. However, specific efficacy findings are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with embolization procedures, but specific adverse events related to desilet are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed efficacy and safety outcomes specific to desilet. Further research is needed to establish comprehensive clinical guidelines and to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for desilet?
Desilet is indicated for use in embolization procedures involving coils, as per FDA documentation.
What outcomes have been reported in clinical studies?
Specific outcomes related to desilet are not detailed in the provided evidence.
What complications have been reported?
Safety data specific to desilet is not detailed in the provided evidence.
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.