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permanent pacing lead w polaris coated tips various models
Oscor
Summary: The permanent pacing lead with polaris coated tips by Oscor is used in cardiac pacing procedures to ensure reliable heart rhythm management. It is primarily utilized by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway 510K
Number K013339 ↗
Decision Date November 8, 2001
Product Code DTB
Device Class Class 3
Evidence 0 studies
This device was cleared through the FDA 510(k) pathway on November 8, 2001. It is manufactured by Oscor and classified as a Class 3 device under product code DTB.
What It Is
The permanent pacing lead is a medical device used in cardiac pacing systems. It features polaris coated tips designed to enhance electrical conductivity and reduce tissue inflammation. The lead is implanted into the heart muscle to deliver electrical impulses that regulate heartbeats, crucial for patients with arrhythmias or heart block.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, which are performed in hospital settings by cardiologists and electrophysiologists. It is suitable for patients with bradycardia, heart block, or other conditions requiring consistent cardiac pacing. The device is used in both initial pacemaker implantation and lead replacement surgeries.
Indications for Use
The FDA indications suggest this device is intended for patients who require permanent cardiac pacing due to conditions like bradycardia or heart block. It is used to maintain adequate heart rate and rhythm in patients with compromised cardiac electrical activity.
Practical Considerations
The leads come in various sizes to accommodate different patient anatomies and are compatible with a range of pacemaker generators. Proper technique during implantation is crucial to ensure optimal lead placement and function. Clinicians should be aware of potential complications like lead dislodgement or infection.
Frequently Asked Questions
What is the permanent pacing lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular heartbeat in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring permanent cardiac pacing due to conditions 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.