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lifeline -unipolar lead 487-05
Intermedics
Summary: The lifeline -unipolar lead 487-05 by Intermedics is a medical device used in cardiac procedures, specifically for pacing. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K823508 ↗
Decision Date
January 14, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The lifeline -unipolar lead 487-05 received FDA clearance through the 510k pathway on January 14, 1983. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The lifeline -unipolar lead 487-05 is a cardiac pacing lead used in conjunction with pacemakers to deliver electrical impulses to the heart. It is designed to be implanted within the heart's chambers, providing a pathway for electrical signals to regulate heartbeats. As a unipolar lead, it uses a single electrode to connect with the heart tissue, which can be advantageous in certain pacing scenarios.
Clinical Applications
This device is commonly used in cardiac pacing procedures, particularly in patients who require long-term pacing support due to conditions like bradycardia. It is frequently utilized in cardiology departments within hospitals and specialized cardiac centers. The device is suitable for adult patients who need reliable pacing support to maintain adequate heart rhythm.
Indications for Use
The lifeline -unipolar lead 487-05 is indicated for patients who require cardiac pacing due to conditions such as slow heart rate (bradycardia) or heart block. It is intended for use in patients who need consistent electrical stimulation to maintain heart function.
Practical Considerations
When using the lifeline -unipolar lead 487-05, clinicians should consider the lead's compatibility with the patient's anatomy and the chosen pacemaker. Proper implantation technique is crucial to ensure optimal performance and longevity. The lead's unipolar design may require specific considerations regarding signal clarity and interference.
Frequently Asked Questions
What is lifeline -unipolar lead 487-05 used for?
It is used for cardiac pacing, delivering electrical impulses to the heart to regulate heartbeats in patients with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital and specialized cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to bradycardia or heart block, providing electrical stimulation to maintain 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.