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electrode leads 030-267 030-268
Telectronics
Summary: Electrode leads 030-267 030-268 by Telectronics are used in electrophysiological applications. Cleared by FDA via 510k pathway. Key evidence includes studies on electrode performance and safety.
FDA Clearance Information
Pathway
510K
Number
K832110 ↗
Decision Date
August 12, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The electrode leads 030-267 030-268 were cleared by the FDA through the 510k pathway on August 12, 1983. Manufactured by Telectronics, they are classified as Class 3 devices under product code DTB.
What It Is
The electrode leads 030-267 030-268 are medical devices used in electrophysiological procedures. They are designed to transmit electrical signals for diagnostic and therapeutic purposes in clinical settings.
Clinical Applications
These electrode leads are commonly used in procedures requiring precise electrical signal transmission, such as intraoperative monitoring and neurological assessments. They are integral in settings where accurate electrophysiological data is critical.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs, prospective, retrospective, and other study types, spanning from 2020 to 2023. These studies explore various aspects of electrode performance and safety.
Reported Outcomes
Published studies report that the electrode leads are effective in transmitting electrical signals with high fidelity. They are noted for their biocompatibility and ability to enhance signal detection in clinical settings. Some studies highlight improvements in electrode design for better clinical outcomes.
Safety Profile
Reported complications include potential issues with electrode positioning and signal interference. However, the studies generally indicate a favorable safety profile with minimal adverse events.
Evidence Limitations
The evidence base is limited by a lack of large-scale, long-term studies. Further research is needed to explore the long-term safety and efficacy of these electrode leads in diverse clinical populations.
Frequently Asked Questions
What are the clinical indications for electrode leads 030-267 030-268?
The clinical indications are detailed in the FDA documentation, primarily involving electrophysiological monitoring and diagnostic procedures.
What outcomes have been reported in clinical studies?
Studies report effective signal transmission and high biocompatibility, with improvements in electrode design enhancing clinical outcomes.
What complications have been reported?
Reported complications include issues with electrode positioning and signal interference, though overall safety is favorable.
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.