đź“Š Evidence-Based Reference
introducer set
Shanghai Kindly Medical Instruments
Summary: The introducer set by Shanghai Kindly Medical Instruments is used primarily for embolization procedures. Key evidence highlights its role in improving procedural success rates in challenging vascular access scenarios.
FDA Clearance Information
Pathway
510K
Number
K180178 ↗
Decision Date
September 10, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer set by Shanghai Kindly Medical Instruments was cleared via the FDA 510(k) pathway on September 10, 2018. It is classified as a Class 2 device under product code DYB.
What It Is
The introducer set is a medical device designed to facilitate the insertion of catheters or other instruments into the vascular system. It is commonly used in embolization procedures to ensure accurate and safe access to targeted vessels.
Clinical Applications
This device is frequently used in procedures requiring precise vascular access, such as embolization of endoleaks or ductal access in sialoendoscopy. It provides clinicians with a reliable method for introducing instruments into the vascular system.
Evidence Summary
The available literature includes 15 studies, encompassing a range of study types such as RCTs and case series, published between 2007 and 2024. These studies explore various clinical applications and outcomes associated with the use of introducer sets.
Reported Outcomes
Published studies report that the introducer set enhances procedural success rates in complex vascular access scenarios. For instance, it has been used successfully in embolization procedures for type 2 endoleaks and in improving ductal access during sialoendoscopy.
Safety Profile
Reported complications include challenges related to malposition and procedural delays, as noted in studies involving PICC placements. However, the use of advanced technologies has been shown to mitigate these issues.
Evidence Limitations
Current evidence is limited by the variability in study designs and the specific clinical contexts in which the introducer set is used. Further research is needed to standardize outcomes and assess long-term safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the introducer set?
The introducer set is indicated for use in procedures requiring vascular access, such as embolization and sialoendoscopy.
What outcomes have been reported in clinical studies?
Studies report improved success rates in vascular access and embolization procedures, with specific applications in managing endoleaks and ductal access.
What complications have been reported?
Safety data indicate potential complications such as malposition and procedural delays, though these can be mitigated with advanced technologies.
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.