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implantable end mush tip leads030-224
Telectronics
Summary: The implantable end mush tip leads by Telectronics are used in cardiac procedures to provide electrical stimulation to the heart. They are typically used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K792321 ↗
Decision Date
December 13, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable end mush tip leads were cleared through the FDA 510(k) pathway on December 13, 1979. Manufactured by Telectronics, this device is classified as a Class III medical device.
What It Is
The implantable end mush tip leads are specialized cardiac leads designed to deliver electrical impulses to the heart muscle, facilitating pacing and rhythm management. These leads are implanted into the heart via a minimally invasive procedure and are connected to a pacemaker or defibrillator. The 'mush tip' design helps ensure stable contact with the heart tissue, optimizing electrical conduction.
Clinical Applications
These leads are commonly used in procedures involving pacemaker or defibrillator implantation, primarily in patients with arrhythmias or heart block. Cardiologists and electrophysiologists use them in settings such as cardiac catheterization labs or operating rooms. They are suitable for adult and pediatric patients requiring long-term cardiac pacing.
Indications for Use
The FDA indications suggest these leads are intended for use in patients who require electrical pacing of the heart. This includes individuals with conditions like bradycardia or heart block, where the heart beats too slowly or irregularly.
Practical Considerations
When selecting leads, clinicians should consider the size and type of the pacemaker or defibrillator for compatibility. Implantation technique requires precision to ensure proper placement and function. Regular follow-up is necessary to monitor lead performance and patient response.
Frequently Asked Questions
What is implantable end mush tip leads used for?
They are used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac procedures.
What are the FDA-cleared indications?
The leads are indicated for patients needing electrical pacing of the heart, such as those with bradycardia 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.