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models ul-804 and bl-801 unipolar leads
Pacesetter Systems
Summary: The UL-804 and BL-801 are unipolar leads manufactured by Pacesetter Systems, primarily used in cardiac pacing. Key evidence includes studies on differentiation of unipolar depression and growth mechanisms.
FDA Clearance Information
Pathway
510K
Number
K791552 ↗
Decision Date
September 4, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The UL-804 and BL-801 unipolar leads were cleared by the FDA via the 510k pathway on September 4, 1979. Manufactured by Pacesetter Systems, they are classified as Class III devices.
What It Is
The UL-804 and BL-801 are unipolar leads designed for use in cardiac pacing systems. These devices are intended to deliver electrical impulses to the heart to maintain an adequate heart rate.
Clinical Applications
Commonly used in patients requiring cardiac pacing, these unipolar leads are integral in managing arrhythmias and ensuring proper cardiac function. They are often employed in scenarios where precise electrical stimulation of the heart is necessary.
Evidence Summary
The available literature includes 10 studies, with a mix of prospective, retrospective, and other study types. The studies span from 2022 to 2025, focusing on various aspects of unipolar mechanisms and applications.
Reported Outcomes
Published studies report on the differentiation between unipolar and bipolar depression using machine learning and EEG analysis, with an accuracy of 76%. Other studies explore unipolar growth mechanisms in bacteria, although these are not directly related to the device's clinical use.
Safety Profile
Reported complications include limited data on device-specific adverse events. The studies primarily focus on theoretical and unrelated biological mechanisms rather than direct clinical safety outcomes.
Evidence Limitations
The evidence lacks direct clinical trials on the UL-804 and BL-801 leads themselves, with most studies focusing on unrelated unipolar mechanisms. Further research is needed to establish direct clinical efficacy and safety outcomes for these devices.
Frequently Asked Questions
What are the clinical indications for models UL-804 and BL-801 unipolar leads?
Refer to FDA documentation for specific clinical indications.
What outcomes have been reported in clinical studies?
Studies report on differentiation of unipolar depression with machine learning, but direct outcomes for the leads are not detailed.
What complications have been reported?
Reported complications include limited data on device-specific adverse events, with a focus on unrelated biological mechanisms.
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.