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permanent lead intraducer
Daig
Summary: The permanent lead introducer by Daig is a medical device used to facilitate the placement of leads in procedures such as cardiac pacing. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K791129 ↗
Decision Date
July 17, 1979
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The permanent lead introducer by Daig was cleared through the FDA 510(k) pathway on July 17, 1979. It is classified as a Class 2 device under product code DYB.
What It Is
The permanent lead introducer is a specialized medical device designed to aid in the insertion of leads, such as those used in cardiac pacemakers or defibrillators. It typically consists of a sheath and dilator system that allows for the smooth passage of leads through the vascular system to the heart. This device is crucial in ensuring accurate lead placement, minimizing trauma to the vessel, and reducing the risk of complications.
Clinical Applications
This device is commonly used in cardiac procedures that require the implantation of pacemaker or defibrillator leads. It is primarily utilized in electrophysiology labs and cardiac catheterization suites. Cardiologists and electrophysiologists use it to ensure precise lead placement in patients requiring cardiac rhythm management, including those with arrhythmias or heart failure.
Indications for Use
The permanent lead introducer is indicated for use in patients who require the implantation of cardiac leads. This includes individuals needing pacemakers or defibrillators for the management of heart rhythm disorders.
Practical Considerations
When using the permanent lead introducer, clinicians should consider the appropriate sizing to match the patient's vascular anatomy. Compatibility with various lead types is essential, and proper technique is crucial to minimize vascular trauma. Familiarity with the device's handling and insertion technique can enhance procedural success.
Frequently Asked Questions
What is the permanent lead introducer used for?
It is used to facilitate the placement of cardiac leads during procedures like pacemaker or defibrillator implantation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, particularly in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring the implantation of cardiac leads, such as those needing pacemakers or defibrillators.
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.