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lifeline bipolar pacing lead mod 466-01
Intermedics
Summary: The Lifeline Bipolar Pacing Lead Mod 466-01 is a cardiac pacing lead used in patients requiring temporary or permanent cardiac pacing. It is typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K781498 ↗
Decision Date
February 1, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Bipolar Pacing Lead Mod 466-01 was cleared via the FDA 510(k) pathway on February 1, 1979. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Lifeline Bipolar Pacing Lead Mod 466-01 is a medical device designed for cardiac pacing. It consists of a lead that delivers electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. This bipolar lead configuration allows for more precise pacing and sensing, reducing interference from external signals.
Clinical Applications
This device is commonly used in cardiac procedures requiring temporary or permanent pacing, such as in patients with bradycardia or heart block. It is typically utilized in cardiology and electrophysiology departments within hospitals. The lead is suitable for a wide range of patients, including those undergoing cardiac surgery or those with pacemaker dependency.
Indications for Use
The device is indicated for patients who need assistance in maintaining adequate heart rhythm due to conditions like bradycardia or heart block. It is suitable for both temporary and permanent pacing needs.
Practical Considerations
The Lifeline Bipolar Pacing Lead is compatible with most pacemakers that accept bipolar leads. Clinicians should ensure proper lead placement and secure connection to the pacemaker. It is important to consider the patient's anatomy and the lead's length and flexibility during implantation.
Frequently Asked Questions
What is Lifeline Bipolar Pacing Lead Mod 466-01 used for?
It is used for cardiac pacing in patients who require temporary or permanent assistance in maintaining 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.