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percutaneous catheter introducer set
Aries Medical
Summary: The percutaneous catheter introducer set by Aries Medical is used for vascular access and catheter placement. Key evidence highlights its role in procedures like REBOA and coronary interventions.
FDA Clearance Information
Pathway
510K
Number
K842004 ↗
Decision Date
July 13, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on July 13, 1984. Manufactured by Aries Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous catheter introducer set is a medical device designed for facilitating the insertion of catheters into the vascular system. It is primarily used in procedures requiring vascular access, such as embolization and coronary interventions.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device aids in procedures like embolization, coronary revascularization, and cerebrospinal fluid diversion. It provides a reliable means of accessing the vascular system for various therapeutic interventions.
Evidence Summary
The literature includes 11 studies, ranging from randomized controlled trials to retrospective analyses, published between 2009 and 2024. These studies explore the device's application in different clinical settings.
Reported Outcomes
Published studies report successful use of the device in procedures such as REBOA and coronary revascularization. The device has been shown to facilitate effective catheter placement, contributing to improved procedural outcomes in both human and veterinary applications.
Safety Profile
Reported complications include potential vascular injury and infection at the insertion site. However, the studies reviewed did not provide detailed safety data, indicating a need for further research on adverse events.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to better understand long-term outcomes and potential complications associated with the device.
Frequently Asked Questions
What are the clinical indications for the percutaneous catheter introducer set?
The device is indicated for vascular access in procedures such as embolization and coronary interventions.
What outcomes have been reported in clinical studies?
Studies report successful catheter placement and improved procedural outcomes in applications like REBOA and coronary revascularization.
What complications have been reported?
Safety data from evidence indicates potential vascular injury and infection at the insertion site, though detailed data is limited.
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.