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model 493-08 polyflex endocardial lead
Intermedics
Summary: The model 493-08 polyflex endocardial lead is a cardiac device used in pacing systems to transmit electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K863781 ↗
Decision Date
November 3, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 493-08 polyflex endocardial lead was cleared by the FDA through the 510(k) pathway on November 3, 1986. Manufactured by Intermedics, it is classified as a Class III medical device.
What It Is
The model 493-08 polyflex endocardial lead is a flexible, insulated wire used in cardiac pacing systems. It is designed to be implanted within the heart's chambers to deliver electrical impulses from a pacemaker, helping to regulate heartbeats in patients with arrhythmias. The lead's design ensures reliable electrical conduction and durability within the cardiac environment.
Clinical Applications
This device is commonly used in the management of bradycardia and other arrhythmias that require pacing intervention. Cardiologists and electrophysiologists typically implant these leads in hospital settings, often during procedures such as pacemaker insertion. It is suitable for adult patients who need long-term cardiac pacing support.
Indications for Use
The model 493-08 polyflex endocardial lead is indicated for patients who require electrical pacing of the heart due to conditions like bradycardia or heart block. It is used to ensure the heart maintains an adequate rate and rhythm.
Practical Considerations
When using the model 493-08 lead, clinicians should consider the appropriate lead length and compatibility with the chosen pacemaker device. Proper implantation technique is crucial to ensure optimal lead positioning and function within the heart.
Frequently Asked Questions
What is the model 493-08 polyflex endocardial lead used for?
It is used to deliver electrical impulses to the heart in patients requiring cardiac pacing, such as those with bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during procedures involving cardiac pacing.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to arrhythmias like bradycardia or heart block.
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.