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type fh endocardial lead
Biotronik Sales
Summary: The Type FH Endocardial Lead by Biotronik Sales is a cardiac device used in pacing systems. It is typically utilized by cardiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K810494 ↗
Decision Date
August 7, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Type FH Endocardial Lead was cleared through the FDA 510(k) pathway on August 7, 1981. Manufactured by Biotronik Sales, it is classified as a Class III device.
What It Is
The Type FH Endocardial Lead is a component of a cardiac pacing system. It is designed to be placed inside the heart to deliver electrical impulses that help regulate heartbeats. This lead is crucial for patients with arrhythmias, ensuring proper cardiac rhythm and function.
Clinical Applications
This device is commonly used in electrophysiology and cardiology settings, particularly for patients with bradycardia or heart block. It is typically implanted in hospital settings by cardiologists or electrophysiologists. The lead is suitable for a wide range of patients, including those with chronic heart conditions requiring long-term pacing.
Indications for Use
The Type FH Endocardial Lead is indicated for patients who need cardiac pacing due to conditions like slow heart rate or heart block. It helps maintain adequate heart rhythm and cardiac output.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators, and proper placement technique is crucial for optimal performance and patient safety.
Frequently Asked Questions
What is the Type FH Endocardial Lead used for?
It is used for cardiac pacing to manage arrhythmias such as bradycardia or heart block.
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 requiring cardiac pacing due to arrhythmias like slow heart rate 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.