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type yc endocardial lead
Biotronik Sales
Summary: The Type YC Endocardial Lead by Biotronik Sales is a cardiac device used in conjunction with pacemakers or defibrillators to manage heart rhythm disorders. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K810491 ↗
Decision Date
March 20, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Type YC Endocardial Lead was cleared through the FDA 510(k) pathway on March 20, 1981, by Biotronik Sales. It is classified as a Class III device under product code DTB.
What It Is
The Type YC Endocardial Lead is a specialized wire that connects a pacemaker or defibrillator to the heart muscle. It is designed to transmit electrical impulses from the device to the heart to regulate heartbeats. The lead is implanted endocardially, meaning it is placed inside the heart chambers, and is crucial for the effective functioning of cardiac rhythm management devices.
Clinical Applications
This device is commonly used in patients requiring cardiac pacing or defibrillation, such as those with bradycardia, heart block, or ventricular arrhythmias. Cardiologists and electrophysiologists typically implant these leads in hospital settings, particularly in cardiac catheterization labs or operating rooms. It is used across various patient populations, including those with congenital heart conditions or acquired heart diseases.
Indications for Use
The Type YC Endocardial Lead is indicated for patients who need electrical stimulation of the heart to maintain an adequate heart rate or rhythm. This includes individuals with conditions like slow heart rates or irregular heart rhythms that could lead to more serious complications.
Practical Considerations
When using the Type YC Endocardial Lead, clinicians should consider the appropriate lead length and compatibility with the specific pacemaker or defibrillator model. Proper implantation technique is crucial to ensure optimal lead positioning and function, and to minimize complications such as lead dislodgement or infection.
Frequently Asked Questions
What is the Type YC Endocardial Lead used for?
It is used to connect pacemakers or defibrillators to the heart to regulate heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients needing heart rhythm management, such as those with bradycardia or arrhythmias.
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.