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telectronics srew-in slim line pacing leads
Daig
Summary: The Telectronics Screw-In Slim Line Pacing Leads are used in cardiac pacing procedures to deliver electrical impulses to the heart. They are primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K864098 ↗
Decision Date
December 5, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Telectronics Screw-In Slim Line Pacing Leads were cleared through the FDA 510(k) pathway on December 5, 1986. Manufactured by Daig, this device is classified as Class III under product code DTB.
What It Is
The Telectronics Screw-In Slim Line Pacing Leads are specialized medical devices used in cardiac pacing. These leads are designed to be screwed into the heart tissue, providing a stable connection for delivering electrical impulses from a pacemaker to the heart. The slim line design allows for easier insertion and reduced risk of vascular damage, making them suitable for long-term pacing needs.
Clinical Applications
These pacing leads are commonly used in procedures to manage arrhythmias, such as bradycardia, where the heart beats too slowly. They are typically used in cardiology and electrophysiology departments within hospitals. The device is suitable for adult patients requiring permanent pacing, and it is often used in conjunction with a pacemaker implantation procedure.
Indications for Use
The FDA indications suggest that these leads are intended for patients who require cardiac pacing due to conditions like heart block or sick sinus syndrome. They are specifically designed for use in patients who need reliable long-term pacing support.
Practical Considerations
The screw-in mechanism of these leads provides secure fixation to the heart tissue, reducing the risk of lead dislodgement. They are compatible with most pacemaker systems, but clinicians should verify compatibility with the specific pacemaker model being used. Proper technique during insertion is crucial to ensure optimal lead placement and function.
Frequently Asked Questions
What is Telectronics Screw-In Slim Line Pacing Leads used for?
These leads are used to deliver electrical impulses from a pacemaker to the heart in patients requiring cardiac pacing.
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 patients needing cardiac pacing due to conditions like heart block or sick sinus syndrome.
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.