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new lead introducer kits various models
Telectronics Pacing Systems
Summary: The lead introducer kits by Telectronics Pacing Systems are used to facilitate the insertion of pacing leads into the heart. These devices are primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K926340 ↗
Decision Date
May 27, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The lead introducer kits were cleared through the FDA 510(k) pathway on May 27, 1993. Manufactured by Telectronics Pacing Systems, these devices are classified as Class 2 under product code DYB.
What It Is
Lead introducer kits are medical devices designed to aid in the insertion of pacing leads into the heart's chambers. They typically consist of a sheath and dilator that help navigate the vasculature and position the lead accurately. These kits are essential in procedures requiring precise lead placement, such as pacemaker or defibrillator implantations.
Clinical Applications
These kits are commonly used in cardiac electrophysiology and interventional cardiology. They are essential in procedures like pacemaker and implantable cardioverter-defibrillator (ICD) insertions, especially in patients with arrhythmias. The devices are used in hospital settings, particularly in catheterization labs or operating rooms, and are crucial for ensuring accurate lead placement in adult and pediatric patients.
Indications for Use
The FDA indications suggest that these kits are intended for use in introducing pacing leads into the heart. They are suitable for patients requiring cardiac pacing, such as those with bradycardia or heart block.
Practical Considerations
Clinicians should be aware of the various sizes available to accommodate different patient anatomies. Compatibility with specific lead types and manufacturers should be verified before use. Proper technique in using the sheath and dilator is crucial to avoid vascular trauma.
Frequently Asked Questions
What is the lead introducer kit used for?
It is used to facilitate the insertion of pacing leads into the heart during procedures like pacemaker or ICD implantations.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for introducing pacing leads into the heart for patients requiring cardiac pacing.
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.