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slimline unipolar endocardial pacing lead 30-401
Telectronics
Summary: The Slimline Unipolar Endocardial Pacing Lead 30-401 is a cardiac pacing lead used in patients requiring cardiac pacing. It is primarily utilized by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K853221 ↗
Decision Date
September 17, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Slimline Unipolar Endocardial Pacing Lead 30-401 was cleared via the FDA 510(k) pathway on September 17, 1985. Manufactured by Telectronics, it is classified as a Class III device.
What It Is
The Slimline Unipolar Endocardial Pacing Lead 30-401 is a medical device designed for cardiac pacing. It is a slimline lead that is inserted into the heart's endocardium to deliver electrical impulses, helping to maintain a regular heart rhythm in patients with arrhythmias. The unipolar design refers to the lead having a single electrode that contacts the heart tissue.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other arrhythmias requiring pacing support. It is typically used in hospital settings by cardiologists and electrophysiologists. The device is suitable for a wide range of patients, including those with congenital heart conditions or acquired heart rhythm disorders.
Indications for Use
The Slimline Unipolar Endocardial Pacing Lead 30-401 is indicated for patients who require cardiac pacing due to arrhythmias such as bradycardia. It is used to ensure that the heart maintains an adequate rate and rhythm.
Practical Considerations
The lead is designed to be compatible with various pacemaker generators. Its slimline design allows for easier insertion and placement within the heart. Clinicians should be aware of the specific sizing and compatibility requirements with the pacing system being used.
Frequently Asked Questions
What is the Slimline Unipolar Endocardial Pacing Lead 30-401 used for?
It is used for cardiac pacing in patients with arrhythmias requiring pacing support.
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 like 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.