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apc implantable pacing lead-flange 3260
American Pacemaker
Summary: The APC Implantable Pacing Lead-Flange 3260 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
K810397 ↗
Decision Date
May 15, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The APC Implantable Pacing Lead-Flange 3260 was cleared via the FDA 510k pathway on May 15, 1981. It is manufactured by American Pacemaker and classified as a Class III device.
What It Is
The APC Implantable Pacing Lead-Flange 3260 is a medical device designed to deliver electrical impulses from an implanted pacemaker to the heart muscle, ensuring proper heart rhythm. It features a flange design for secure placement and stability within the heart. This lead is crucial in managing patients with bradycardia or other rhythm disorders requiring pacing support.
Clinical Applications
This device is commonly used in cardiology for patients requiring long-term cardiac pacing. It is typically implanted during a surgical procedure in a hospital setting. The lead is suitable for a wide range of patients, including those with heart block or sick sinus syndrome, and is often used in conjunction with pacemakers in adult and geriatric populations.
Indications for Use
The device is indicated for patients who need electrical pacing to maintain an adequate heart rate due to conditions like heart block or bradycardia. It helps ensure that the heart beats at a regular pace, preventing symptoms such as dizziness or fainting.
Practical Considerations
The APC Implantable Pacing Lead-Flange 3260 is compatible with most pacemaker systems. It is important to ensure proper sizing and placement during implantation to avoid lead dislodgement. Clinicians should be familiar with the surgical technique for optimal outcomes.
Frequently Asked Questions
What is the APC Implantable Pacing Lead-Flange 3260 used for?
It is used to deliver electrical impulses from a pacemaker to the heart to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to 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.