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pacepath implantable endocard pacing ld
Pacesetter Systems
Summary: The Pacepath Implantable Endocard Pacing Lead is a cardiac device used for pacing the heart in patients with arrhythmias. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K811200 ↗
Decision Date
August 13, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Pacepath Implantable Endocard Pacing Lead was cleared through the FDA 510k pathway on August 13, 1981. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The Pacepath Implantable Endocard Pacing Lead is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias. It is implanted in the heart's endocardial surface and connected to a pacemaker. The device helps regulate heartbeats, ensuring that the heart functions effectively.
Clinical Applications
This device is commonly used in patients with bradycardia or heart block, where the heart beats too slowly. It is typically utilized in cardiology departments within hospitals and is crucial for patients who require long-term pacing support. The device is often used in adult patients but can also be adapted for pediatric use in specialized cases.
Indications for Use
The device is intended for patients with conditions that cause irregular heartbeats, such as bradycardia or heart block. It helps maintain a regular heart rhythm by providing electrical stimulation to the heart.
Practical Considerations
When considering this device, clinicians should be aware of the typical lead sizes and ensure compatibility with the pacemaker generator. Proper implantation technique is crucial to avoid lead dislodgement and ensure optimal pacing performance.
Frequently Asked Questions
What is Pacepath Implantable Endocard Pacing LD used for?
It is used to regulate heartbeats in patients with arrhythmias, such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists in hospital settings typically use this device for patients requiring cardiac pacing.
What are the FDA-cleared indications?
The device is indicated for patients with irregular heartbeats, such as those with bradycardia or heart block, to maintain regular heart rhythm.
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.