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int introducer set
Shanghai Kindly Medical Instruments
Summary: The int introducer set by Shanghai Kindly Medical Instruments is used for embolization-coils procedures. It is FDA 510k cleared with evidence from two studies highlighting its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K222647 ↗
Decision Date
September 13, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The int introducer set was cleared by the FDA through the 510k pathway on September 13, 2022. Manufactured by Shanghai Kindly Medical Instruments, it is classified as a Class 2 device.
What It Is
The int introducer set is a medical device designed for use in embolization-coils procedures. It facilitates the introduction of instruments into the vascular system, aiding in the delivery of therapeutic agents.
Clinical Applications
Commonly used in interventional radiology, the int introducer set is employed in procedures requiring precise vascular access, such as embolization for treating vascular abnormalities.
Evidence Summary
The available literature includes two studies, with publication years ranging from 2020 to 2025. These studies provide insights into the device's application and effectiveness in clinical settings.
Reported Outcomes
Published studies report that the int introducer set is effective in facilitating reliable ductal access during sialoendoscopy. The device's design allows for precise insertion, improving procedural success rates.
Safety Profile
Reported complications include challenges in insertion for beginners, as noted in sialoendoscopy procedures. However, no significant adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for int introducer set?
The int introducer set is indicated for use in embolization-coils procedures, facilitating vascular access for therapeutic interventions.
What outcomes have been reported in clinical studies?
Studies report effective ductal access and improved procedural success rates in sialoendoscopy.
What complications have been reported?
Safety data indicate challenges in insertion for beginners, with no significant adverse events reported.
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.