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shoocin introducer kit
Lepu Medical Technology (Beijing)
Summary: The Shoocin Introducer Kit is a medical device used primarily for embolization procedures. Key evidence highlights its utility in reducing complications associated with traditional methods.
FDA Clearance Information
Pathway
510K
Number
K172099 ↗
Decision Date
October 5, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Shoocin Introducer Kit was cleared via the FDA 510(k) pathway on October 5, 2017. It is manufactured by Lepu Medical Technology and classified as a Class 2 device.
What It Is
The Shoocin Introducer Kit is designed for embolization procedures, facilitating the introduction of embolization coils. It is intended for use in clinical settings where precise placement of coils is necessary.
Clinical Applications
Commonly used in procedures requiring embolization, the Shoocin Introducer Kit is applicable in scenarios such as vascular occlusions and aneurysm treatments, providing clinicians with a reliable tool for coil deployment.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2016 and 2024. These studies explore the device's efficacy and safety in clinical applications.
Reported Outcomes
Published studies report that the Shoocin Introducer Kit improves procedural success rates and reduces the risk of complications compared to traditional methods. It has shown effectiveness in facilitating precise coil placement in embolization procedures.
Safety Profile
Reported complications include minor procedural discomfort and rare instances of device-related infection. Overall, the safety profile is favorable, with low incidence of adverse events.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety and efficacy profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Shoocin Introducer Kit?
The Shoocin Introducer Kit is indicated for use in embolization procedures, particularly for the introduction of embolization coils in vascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success rates and reduced complication risks with the use of the Shoocin Introducer Kit compared to traditional methods.
What complications have been reported?
Safety data indicate minor procedural discomfort and rare device-related infections as reported complications.
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.