đź“‹ FDA Reference
permanent lead intraducer
Daig
Summary: The permanent lead introducer by Daig is a medical device used primarily in cardiology for the insertion of leads into the heart. It is typically used by cardiologists and electrophysiologists during procedures such as pacemaker or defibrillator implantation.
FDA Clearance Information
Pathway
510K
Number
K800356 ↗
Decision Date
May 28, 1980
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The permanent lead introducer by Daig was cleared through the FDA 510k pathway on May 28, 1980. 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 facilitate the insertion of electrical leads into the heart. It consists of a sheath and dilator system that allows for the smooth passage of leads through the venous system and into the cardiac chambers. This device is crucial in procedures that require precise placement of leads for devices like pacemakers and implantable cardioverter-defibrillators (ICDs).
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization suites. It is essential for procedures involving the implantation of cardiac rhythm management devices, such as pacemakers and ICDs. Cardiologists and electrophysiologists use it to ensure accurate lead placement in patients with arrhythmias or heart failure who require device therapy.
Indications for Use
The permanent lead introducer is indicated for use in patients requiring the implantation of cardiac leads, typically for pacemakers or defibrillators. It is used in conditions where electrical stimulation of the heart is necessary to maintain adequate heart rhythm.
Practical Considerations
When using the permanent lead introducer, clinicians should consider the size and type of leads being used to ensure compatibility. The technique involves careful manipulation to avoid vascular injury, and familiarity with the device's handling characteristics is important for successful lead placement.
Frequently Asked Questions
What is the permanent lead introducer used for?
It is used for the insertion of cardiac leads during procedures like pacemaker or defibrillator implantation.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device during cardiac rhythm management procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients needing cardiac lead implantation, such as those requiring 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.