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percutaneous catheter introducer set
Vertex Medical
Summary: The percutaneous catheter introducer set by Vertex Medical is a device used for vascular access in various clinical settings. Key evidence highlights its application in procedures like REBOA and coronary revascularization.
FDA Clearance Information
Pathway
510K
Number
K822593 ↗
Decision Date
September 28, 1982
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous catheter introducer set was cleared by the FDA through the 510(k) pathway on September 28, 1982. It is manufactured by Vertex Medical and classified as a Class 2 device.
What It Is
The percutaneous catheter introducer set is designed for vascular access, facilitating the introduction of catheters into the vascular system. It is commonly used in procedures requiring precise catheter placement.
Clinical Applications
This device is frequently used in interventional radiology and cardiology for procedures such as embolization and coronary revascularization. It is essential in settings requiring reliable vascular access.
Evidence Summary
The literature includes 11 studies ranging from 2009 to 2024, encompassing RCTs, prospective, and retrospective studies. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report successful use in procedures like REBOA and coronary revascularization, highlighting its efficacy in achieving vascular access. The device has been shown to facilitate improved procedural outcomes in complex interventions.
Safety Profile
Reported complications include potential vascular injury and infection at the insertion site. However, the overall safety profile is considered acceptable with proper technique and monitoring.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some studies. Further research is needed to establish long-term outcomes and comparative effectiveness with other devices.
Frequently Asked Questions
What are the clinical indications for percutaneous catheter introducer set?
The device is indicated for vascular access in procedures like embolization and coronary interventions.
What outcomes have been reported in clinical studies?
Studies report successful vascular access and improved procedural outcomes in interventions like REBOA and coronary revascularization.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and infection, though these are generally manageable with proper technique.
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.