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implantable electrode leads 033-400 402 and 436
Telectronics
Summary: The implantable electrode leads 033-400 402 and 436 by Telectronics are used in cardiac pacing and monitoring. They are typically used by cardiologists in hospital settings for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K884278 ↗
Decision Date
December 15, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable electrode leads by Telectronics were cleared through the FDA 510k pathway on December 15, 1988. They are classified as Class III devices under product code DTB.
What It Is
These implantable electrode leads are designed for use in cardiac pacing systems. They are inserted into the heart to deliver electrical impulses that help regulate heartbeats. The leads are crucial components in pacemaker systems, ensuring proper electrical conduction to maintain cardiac rhythm.
Clinical Applications
These leads are commonly used in procedures involving cardiac pacemaker implantation. They are utilized by cardiologists and electrophysiologists in hospital settings, particularly in patients with arrhythmias or heart block. The leads are suitable for adult and pediatric patients requiring long-term cardiac rhythm management.
Indications for Use
The FDA indications suggest these leads are intended for patients with conditions that require electrical stimulation of the heart, such as bradycardia or heart block. They are used to ensure the heart beats at a regular pace.
Practical Considerations
The leads are available in various lengths to accommodate different patient anatomies. They are compatible with most pacemaker devices and require careful handling during implantation to ensure optimal placement and function.
Frequently Asked Questions
What is implantable electrode leads 033-400 402 and 436 used for?
These leads are used for cardiac pacing and monitoring in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings.
What are the FDA-cleared indications?
These leads are indicated for patients needing electrical stimulation 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.