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radialseal introducer kit
Great Batch Medical
Summary: The Radialseal Introducer Kit by Great Batch Medical is a device used for vascular access procedures. It is primarily indicated for embolization-coils and has been FDA cleared via the 510k pathway. Key evidence highlights its utility in reducing complications associated with traditional methods.
FDA Clearance Information
Pathway
510K
Number
K181855 ↗
Decision Date
July 26, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Radialseal Introducer Kit was cleared by the FDA through the 510k pathway on July 26, 2018. It is manufactured by Great Batch Medical and classified as a Class 2 medical device.
What It Is
The Radialseal Introducer Kit is designed to facilitate vascular access by providing a stable and secure entry point for guidewires and catheters. It is intended for use in procedures requiring precise and reliable vascular access, such as embolization-coil placements.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Radialseal Introducer Kit is employed in scenarios where secure vascular access is critical. It is particularly useful in procedures involving embolization-coils, where minimizing vascular trauma is essential.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses, with publication years ranging from 2016 to 2024. These studies provide insights into the device's efficacy and safety profile.
Reported Outcomes
Published studies report that the Radialseal Introducer Kit improves procedural success rates and reduces complications associated with traditional vascular access methods. The device has been shown to enhance the stability of guidewire insertion, thereby increasing the overall efficiency of vascular procedures.
Safety Profile
Reported complications include potential vascular trauma and infection, although these are less frequent compared to traditional methods. The device's design aims to minimize such risks by providing a more controlled and stable access point.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to establish the device's efficacy across diverse patient populations and procedural contexts.
Frequently Asked Questions
What are the clinical indications for the Radialseal Introducer Kit?
The Radialseal Introducer Kit is indicated for use in procedures requiring vascular access, particularly in the placement of embolization-coils.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success rates and reduced complications compared to traditional methods.
What complications have been reported?
Safety data from evidence indicate potential complications such as vascular trauma and infection, though these are less common with the Radialseal Introducer Kit.
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.