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pacepath implant endocard pacing lead
Pacesetter Systems
Summary: The Pacepath Implant Endocard Pacing Lead is a medical device used for cardiac pacing, primarily by cardiologists in hospital settings. It is designed to help manage heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K810286 ↗
Decision Date
November 27, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Pacepath Implant Endocard Pacing Lead was cleared through the FDA 510k pathway on November 27, 1981. Manufactured by Pacesetter Systems, it is classified as a Class 3 device.
What It Is
The Pacepath Implant Endocard Pacing Lead is an implantable device used to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It is typically used in patients with arrhythmias or heart block. The lead is placed inside the heart via the venous system and connected to a pacemaker, which regulates the heart's electrical activity.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is indicated for patients with bradycardia or other rhythm disturbances that require pacing. The lead is often used in conjunction with pacemakers in patients who have had heart block or require long-term pacing support.
Indications for Use
The Pacepath Implant Endocard Pacing Lead is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is suitable for those who require a reliable method to maintain heart rhythm.
Practical Considerations
When using the Pacepath Implant Endocard Pacing Lead, clinicians should consider the lead's compatibility with different pacemaker models. Proper placement technique is crucial to ensure effective pacing and minimize complications. The lead comes in various lengths to accommodate different patient anatomies.
Frequently Asked Questions
What is the Pacepath Implant Endocard Pacing Lead used for?
It is used for cardiac pacing in patients with rhythm disorders like bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions such as 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.