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silicone bipolar lead models 1136t 1142t 1146t
Siemens-Pacesetter
Summary: The silicone bipolar lead models 1136t, 1142t, and 1146t are cardiac pacing leads used in conjunction with pacemakers. They are primarily utilized by cardiologists in settings such as hospitals and specialized cardiac centers.
FDA Clearance Information
Pathway
510K
Number
K930876 ↗
Decision Date
June 15, 1994
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
These silicone bipolar leads were cleared through the FDA 510k pathway on June 15, 1994. Manufactured by Siemens-Pacesetter, they are classified as Class III medical devices.
What It Is
The silicone bipolar lead models 1136t, 1142t, and 1146t are specialized cardiac pacing leads designed for use with pacemakers. They are made of silicone, which provides flexibility and durability, and feature a bipolar configuration that allows for precise electrical conduction to stimulate the heart. These leads are integral components in cardiac pacing systems, ensuring reliable heart rhythm management.
Clinical Applications
These leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with arrhythmias or heart block. Cardiologists and electrophysiologists typically use these devices in hospital settings, especially in cardiac catheterization labs or operating rooms. They are suitable for a wide range of patients, including those with chronic heart conditions requiring long-term pacing support.
Indications for Use
The FDA-cleared indications for these leads include their use in patients requiring cardiac pacing due to arrhythmias or heart block. They are designed to ensure consistent electrical stimulation of the heart to maintain an adequate heart rate.
Practical Considerations
These leads come in various lengths to accommodate different patient anatomies and are compatible with a range of pacemaker models. Proper technique during implantation is crucial to ensure optimal lead placement and function. Clinicians should be familiar with the handling and insertion techniques specific to silicone bipolar leads.
Frequently Asked Questions
What is silicone bipolar lead models 1136t 1142t 1146t used for?
These leads are used for cardiac pacing in patients with arrhythmias or heart block, ensuring consistent heart rhythm management.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings, particularly in cardiac catheterization labs and operating rooms.
What are the FDA-cleared indications?
These leads are 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.