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shoocin introducer kit
Lepu Medical Technology (Beijing)
Summary: The Shoocin Introducer Kit is a medical device used primarily for embolization-coils procedures. It has been FDA-cleared and is supported by clinical studies that explore its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K123475 ↗
Decision Date
February 3, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Shoocin Introducer Kit was cleared by the FDA through the 510(k) pathway on February 3, 2014. It is manufactured by Lepu Medical Technology and classified as a Class 2 device.
What It Is
The Shoocin Introducer Kit is designed for the introduction of embolization coils. It facilitates the placement of coils in vascular procedures, aiding in the treatment of aneurysms and other vascular conditions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for embolization procedures. It is particularly useful in scenarios requiring precise coil placement to occlude blood vessels.
Evidence Summary
The available literature includes 10 studies, covering various study types such as RCTs and retrospective analyses, with publication dates ranging from 2016 to 2024.
Reported Outcomes
Published studies report that the Shoocin Introducer Kit is effective in facilitating embolization procedures, with improved precision in coil placement. The device has shown utility in reducing procedure time and enhancing success rates in vascular interventions.
Safety Profile
Reported complications include potential dislodgement of the needle during procedures, as noted in some studies. However, overall safety profiles suggest that adverse events are minimal and manageable.
Evidence Limitations
The evidence base is limited by a lack of large-scale, long-term studies. Further research is needed to explore the device's efficacy across diverse patient populations and to assess long-term outcomes.
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 placement of embolization coils in vascular interventions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved precision in coil placement and reduced procedure times, enhancing the success rates of vascular interventions.
What complications have been reported?
Safety data from evidence indicate potential needle dislodgement during procedures, but overall adverse events are minimal and manageable.
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.