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model 1148t transvenous screw-in lead
Siemens-Pacesetter
Summary: The model 1148t transvenous screw-in lead is a medical device used primarily in cardiac pacing. It is utilized by cardiologists and electrophysiologists to ensure stable electrical conduction in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K925347 ↗
Decision Date
June 10, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 1148t transvenous screw-in lead was cleared through the FDA 510(k) pathway on June 10, 1993. Manufactured by Siemens-Pacesetter, it is classified as a Class III device under product code DTB.
What It Is
The model 1148t transvenous screw-in lead is a specialized lead used in cardiac pacing systems. It features a screw-in mechanism that allows for secure attachment to the heart tissue, ensuring reliable electrical conduction. This device is critical for maintaining heart rhythm in patients with arrhythmias or other cardiac conduction disorders.
Clinical Applications
This lead is commonly used in procedures involving pacemaker implantation, particularly in patients with bradycardia or heart block. It is typically employed in hospital settings by cardiologists and electrophysiologists. The device is suitable for a wide range of patients, including those with chronic heart conditions requiring long-term pacing solutions.
Indications for Use
The FDA indications for the model 1148t transvenous screw-in lead include its use in patients who require cardiac pacing due to arrhythmias or heart block. It is designed to provide stable and reliable electrical conduction to support heart function.
Practical Considerations
When using the model 1148t lead, clinicians should consider the appropriate sizing to match patient anatomy and ensure compatibility with the chosen pacemaker system. The screw-in mechanism requires careful technique to avoid dislodgement and ensure optimal performance.
Frequently Asked Questions
What is the model 1148t transvenous screw-in lead used for?
It is used for cardiac pacing in patients who require stable electrical conduction due to arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings for pacemaker implantation.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias 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.