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apc implantabel pacing lead model 3264
American Pacemaker
Summary: The APC Implantable Pacing Lead Model 3264 is a cardiac pacing lead used in conjunction with pacemakers to manage arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K810399 ↗
Decision Date
May 15, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The APC Implantable Pacing Lead Model 3264 was cleared via the FDA 510(k) pathway on May 15, 1981, by American Pacemaker. It is classified as a Class III device under product code DTB.
What It Is
The APC Implantable Pacing Lead Model 3264 is a medical device designed to connect a pacemaker to the heart muscle, facilitating electrical stimulation to regulate heart rhythm. It is an essential component in cardiac pacing systems, ensuring the delivery of electrical impulses to maintain adequate heart rate and rhythm. The lead is typically inserted transvenously and positioned within the heart chambers.
Clinical Applications
This pacing lead is commonly used in procedures to treat bradycardia, where the heart beats too slowly. Cardiologists and electrophysiologists typically use it during pacemaker implantation surgeries. It is suitable for adult patients who require long-term cardiac pacing, often performed in hospital cardiac units or specialized electrophysiology labs.
Indications for Use
The APC Implantable Pacing Lead Model 3264 is indicated for patients with arrhythmias that result in slow heart rates, such as those with sick sinus syndrome or heart block. It is used to ensure the heart maintains an adequate rate and rhythm.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most pacemaker models. Proper placement and secure fixation within the heart are critical to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is the APC Implantable Pacing Lead Model 3264 used for?
It is used to connect a pacemaker to the heart to regulate heart rhythm 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?
It is indicated for patients with arrhythmias leading to slow heart rates, such as sick sinus syndrome 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.