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endocaridal pacing lead unipolar 477
Intermedics
Summary: The Endocardial Pacing Lead Unipolar 477 is a cardiac pacing lead used in conjunction with pacemakers to manage arrhythmias. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K781525 ↗
Decision Date
February 1, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Endocardial Pacing Lead Unipolar 477 was cleared through the FDA 510(k) pathway on February 1, 1979, and is manufactured by Intermedics. It is classified as a Class III device under product code DTB.
What It Is
The Endocardial Pacing Lead Unipolar 477 is a medical device designed for cardiac pacing. It consists of a lead that is inserted into the heart's endocardial surface to deliver electrical impulses from an external pacemaker. This helps regulate heart rhythms in patients with arrhythmias, ensuring proper cardiac function.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically use this device in hospital settings, especially in cardiac catheterization labs or during surgical implantation procedures. It is suitable for adult patients requiring long-term pacing solutions.
Indications for Use
The device is indicated for patients who require cardiac pacing due to arrhythmias such as bradycardia. It is used to maintain adequate heart rates in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The lead is typically compatible with a range of pacemakers, but clinicians should ensure compatibility with specific models. Proper placement technique is crucial for optimal performance, and sizing should be considered based on patient anatomy.
Frequently Asked Questions
What is the Endocardial Pacing Lead Unipolar 477 used for?
It is used for cardiac pacing in patients with arrhythmias to regulate heart rhythms.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias such as bradycardia.
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.