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modified labeling to permanent lead introducer
Daig
Summary: The modified labeling to permanent lead introducer by Daig is a Class 2 medical device used primarily in embolization procedures. Key evidence highlights its role in facilitating lead placement with minimal complications.
FDA Clearance Information
Pathway
510K
Number
K894431 ↗
Decision Date
September 6, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 6, 1989. Manufactured by Daig, it is classified as a Class 2 device under product code DYB.
What It Is
The modified labeling to permanent lead introducer is a medical device designed to assist in the placement of permanent leads during embolization procedures. It is intended for use by clinicians in a controlled medical setting.
Clinical Applications
Commonly used in procedures requiring the introduction of permanent leads, this device is essential in embolization-coil applications. It provides a reliable method for clinicians to ensure accurate lead placement.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, with publication years ranging from 1992 to 2024. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the device effectively facilitates lead placement with a high success rate in embolization procedures. Clinical outcomes indicate improved procedural efficiency and reduced lead-related complications.
Safety Profile
Reported complications include minimal adverse events related to the device's use, with studies indicating a low incidence of lead-related infections. Overall, the device is considered safe for its intended use.
Evidence Limitations
While the available studies provide valuable insights, there are gaps in long-term outcome data and comparative studies with other devices. Further research is needed to explore these areas and validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for modified labeling to permanent lead introducer?
The device is indicated for use in embolization procedures requiring permanent lead placement, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report successful lead placement with improved procedural efficiency and minimal complications.
What complications have been reported?
Safety data indicate a low incidence of lead-related infections and other adverse events.
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.