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permanent implantable fh endocardial leads w tip
Biotronik, Gmbh &
Summary: The permanent implantable FH endocardial leads are used in cardiac procedures to provide electrical connection to the heart tissue. Primarily used by cardiologists, these leads are crucial in managing patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K910608 ↗
Decision Date
July 30, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on July 30, 1991. Manufactured by Biotronik, Gmbh &, it is classified as a Class III device under product code DTB.
What It Is
The permanent implantable FH endocardial leads are medical devices designed to be implanted in the heart to deliver electrical impulses for pacing. These leads connect to a pacemaker or defibrillator, ensuring proper cardiac function in patients with arrhythmias or heart block. The leads are typically inserted via a transvenous approach, allowing for minimally invasive placement.
Clinical Applications
These leads are commonly used in cardiology, particularly in electrophysiology and interventional cardiology settings. They are essential in procedures for patients with bradycardia, heart block, or other conditions requiring cardiac pacing. The device is typically used in hospital settings, including operating rooms and catheterization labs, and is suitable for adult and pediatric populations requiring long-term cardiac rhythm management.
Indications for Use
The FDA indications suggest that this device is intended for patients needing permanent pacing due to heart rhythm disorders. It is suitable for individuals with conditions like complete heart block or symptomatic bradycardia.
Practical Considerations
Clinicians should consider the lead's compatibility with various pacemaker models and ensure proper sizing for the patient's anatomy. The implantation technique requires familiarity with transvenous lead placement and fluoroscopic guidance to ensure accurate positioning within the heart.
Frequently Asked Questions
What is permanent implantable FH endocardial leads used for?
They are used to provide electrical pacing to the heart in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring permanent cardiac pacing due to conditions like heart block or bradycardia.
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.