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pacing leads model 3262vu vb 3362vu vb 3380 3390
Pace Medical
Summary: Pacing leads model 3262vu vb 3362vu vb 3380 3390 by Pace Medical are used in cardiac pacing. Cleared by FDA via 510k pathway. Key evidence includes studies on cardiac function and risk prediction.
FDA Clearance Information
Pathway
510K
Number
K874743 ↗
Decision Date
January 19, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing leads were cleared by the FDA through the 510k pathway on January 19, 1988. Manufactured by Pace Medical, they are classified as Class 3 devices.
What It Is
These pacing leads are used in cardiac pacing to maintain heart rhythm. They are designed for implantation in patients requiring electrical stimulation of the heart.
Clinical Applications
Commonly used in scenarios requiring cardiac pacing, such as bradycardia or heart block. They are integral in maintaining adequate heart rate and rhythm in patients with conduction system disorders.
Evidence Summary
The literature includes three studies, with types ranging from RCTs to retrospective analyses, published between 2021 and 2024. These studies explore cardiac function and risk prediction models.
Reported Outcomes
Published studies report improvements in cardiac function and risk prediction for sudden cardiac death. The AI model study highlights advancements in detecting acute myocardial infarction.
Safety Profile
Reported complications include potential arrhythmias and device-related issues, as inferred from the study on Na+/Ca2+ exchanger inhibitors. No direct safety data on the pacing leads were provided.
Evidence Limitations
The evidence is limited by a lack of direct studies on the pacing leads themselves. Further research is needed to establish specific efficacy and safety profiles for these devices.
Frequently Asked Questions
What are the clinical indications for pacing leads model 3262vu vb 3362vu vb 3380 3390?
The clinical indications are detailed in the FDA documentation, primarily for cardiac pacing in patients with heart rhythm disorders.
What outcomes have been reported in clinical studies?
Studies report improved cardiac function and effective risk prediction for sudden cardiac death, though not directly linked to the pacing leads.
What complications have been reported?
Reported complications include arrhythmias and device-related issues, based on related cardiac studies.
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.