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intravascular introducer system
Applied Medical Resources
Summary: The intravascular introducer system by Applied Medical Resources is used for vascular access in embolization procedures. Key evidence includes studies on device efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K063658 ↗
Decision Date
September 12, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 12, 2007. It is manufactured by Applied Medical Resources and classified as a Class 2 device under product code DYB.
What It Is
The intravascular introducer system is designed to facilitate vascular access for the introduction of catheters and other devices into the vascular system. It is primarily used in embolization procedures and other interventional radiology applications.
Clinical Applications
Commonly used in procedures requiring vascular access, such as embolization of vascular anomalies or tumors. It is also utilized in interventional cardiology and radiology for diagnostic and therapeutic purposes.
Evidence Summary
The literature includes 13 studies, comprising various study types such as RCTs and case series, published between 2022 and 2024. These studies explore the device's application in different clinical scenarios.
Reported Outcomes
Published studies report successful use of the intravascular introducer system in facilitating vascular access for embolization and other procedures. The device has been shown to be effective in maintaining patency and reducing procedure time in clinical settings.
Safety Profile
Reported complications include potential for air embolism and vascular trauma, as highlighted in studies focusing on air detection and purging systems. Overall, the device is considered safe with proper use and monitoring.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to explore the device's efficacy in diverse patient populations and complex clinical scenarios.
Frequently Asked Questions
What are the clinical indications for intravascular introducer system?
The device is indicated for vascular access in embolization procedures and other interventional radiology applications.
What outcomes have been reported in clinical studies?
Studies report effective vascular access facilitation, reduced procedure time, and maintained patency.
What complications have been reported?
Safety data indicate potential for air embolism and vascular trauma, which can be mitigated with proper use.
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.