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resubmission of model 030-437 implant electrode
Telectronics
Summary: The Model 030-437 Implant Electrode by Telectronics is an FDA-cleared medical device used in the management of cardiac conditions. It is typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K870610 ↗
Decision Date
March 20, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 030-437 Implant Electrode was cleared through the FDA 510(k) pathway on March 20, 1987. It is manufactured by Telectronics and classified as a Class III device.
What It Is
The Model 030-437 Implant Electrode is a medical device designed for implantation in patients requiring cardiac rhythm management. It functions as part of a pacemaker or defibrillator system, delivering electrical impulses to the heart muscle to maintain an appropriate heart rate and rhythm. This device is crucial in managing arrhythmias and preventing sudden cardiac arrest.
Clinical Applications
This implant electrode is commonly used in procedures involving the implantation of pacemakers or defibrillators. It is utilized in cardiology and electrophysiology settings, particularly for patients with bradycardia, heart block, or other arrhythmias. The device is typically used in hospital settings, including operating rooms and cardiac catheterization labs.
Indications for Use
The Model 030-437 Implant Electrode is indicated for patients with cardiac arrhythmias requiring electrical stimulation to maintain a regular heartbeat. It is suitable for individuals with conditions like bradycardia or heart block.
Practical Considerations
When considering this device, clinicians should note the typical sizing and compatibility with specific pacemaker or defibrillator models. Proper technique during implantation is crucial to ensure optimal device function and patient safety.
Frequently Asked Questions
What is the Model 030-437 Implant Electrode used for?
It is used for cardiac rhythm management in patients with arrhythmias, functioning as part of a pacemaker or defibrillator system.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac arrhythmias.
What are the FDA-cleared indications?
The device is indicated for patients with cardiac arrhythmias requiring electrical stimulation to maintain a regular heartbeat.
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.