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access percutaneous introducer set
Access Devices
Summary: The access percutaneous introducer set is a medical device used for vascular access in various procedures. It is primarily used in embolization-coil procedures. Key evidence includes studies on its use in complex endovascular repairs.
FDA Clearance Information
Pathway
510K
Number
K822834 ↗
Decision Date
November 1, 1982
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The access percutaneous introducer set was cleared by the FDA through the 510(k) pathway on November 1, 1982. It is manufactured by Access Devices and classified as a Class 2 device.
What It Is
The access percutaneous introducer set is designed to facilitate vascular access for the introduction of catheters or other medical devices. It is commonly used in procedures requiring precise vascular entry, such as embolization-coil placements.
Clinical Applications
This device is frequently used in interventional radiology and cardiology for procedures like embolization and endovascular repairs. It provides a reliable method for accessing the vascular system in minimally invasive procedures.
Evidence Summary
The literature includes 13 studies, comprising various study types such as RCTs and case series, conducted between 2021 and 2026. These studies explore the device's application in different clinical settings.
Reported Outcomes
Published studies report successful use of the device in procedures like percutaneous transapical intraventricular septum pacing and transgastric jejunal tube placements. Outcomes indicate effective vascular access with minimal complications.
Safety Profile
Reported complications include potential vascular injury and device-related infections. However, the studies generally indicate a favorable safety profile with appropriate use.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for more randomized controlled trials. Further research is needed to explore long-term outcomes and device performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for access percutaneous introducer set?
The device is indicated for use in procedures requiring vascular access, such as embolization-coil placements and endovascular repairs.
What outcomes have been reported in clinical studies?
Studies report effective vascular access with successful procedural outcomes in various clinical settings.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and infections, though these are generally infrequent 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.