📊 Evidence-Based Reference
Model RF D RX D Pacemaker Leads
Summary: The model rf d rx d pacemaker leads by Oscor are FDA-cleared devices used in cardiac pacing. Key evidence includes 7 studies, though none directly related to this device.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823895 ↗
Decision Date ?
April 30, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The model rf d rx d pacemaker leads were cleared through the FDA 510(k) pathway on April 30, 1983. Manufactured by Oscor, they are classified as Class III devices.
What It Is
The model rf d rx d pacemaker leads are designed for use in cardiac pacing, facilitating electrical conduction between the pacemaker and the heart muscle. They are intended for patients requiring cardiac rhythm management.
FDA-Cleared Indications
- Use as a component of a cardiac pacemaker system for patients who require electrical pacing.
- Use to conduct pacing impulses between a pacemaker pulse generator and the heart.
Clinical Applications
- Permanent cardiac pacing for clinically significant bradycardia when prescribed by a cardiac electrophysiology or cardiology team.
- Connection of an implanted pacemaker generator to the appropriate cardiac chamber.
- Delivery of electrical pacing impulses to cardiac tissue as part of a complete pacemaker system.
Evidence Summary
The literature includes 7 studies, though none directly pertain to the model rf d rx d pacemaker leads. The studies range from 2021 to 2025 and cover various medical topics unrelated to this device.
Reported Outcomes
Published studies report no direct outcomes related to the model rf d rx d pacemaker leads. The available evidence does not provide specific efficacy findings for this device.
Safety Profile
Reported complications include no specific safety data for the model rf d rx d pacemaker leads. The evidence provided does not address adverse events or complications for this device.
Evidence Limitations
The current evidence lacks direct studies on the model rf d rx d pacemaker leads, highlighting a gap in device-specific research. Further investigation is needed to assess the efficacy and safety of these leads.
Practical Considerations
- The record identifies the device category but does not provide specific lead lengths, diameters, fixation mechanism, connector type, or chamber configuration; these details must be confirmed in the original labeling.
- Compatibility with the pacemaker pulse generator and any adapters should be verified before implantation.
- MRI safety cannot be determined from this FDA record. Do not assume the lead is MRI-conditional; confirm the complete implanted system and manufacturer labeling.
- Implantation requires sterile technique, fluoroscopic or other appropriate imaging, cardiac monitoring, and management of risks such as bleeding, infection, lead dislodgment, perforation, and arrhythmia.
- The lead is intended for use by qualified clinicians familiar with pacemaker implantation, testing, follow-up, and device-specific contraindications.
Frequently Asked Questions
What are the clinical indications for model rf d rx d pacemaker leads?
Clinical indications are detailed in the FDA documentation, primarily for cardiac pacing needs.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported for the model rf d rx d pacemaker leads in the provided evidence.
What complications have been reported?
No safety data or complications have been reported for this device in the provided evidence.
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.