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medtronis r pacing leads and lead adaptors modif
Medtronic Vascular
Summary: The Medtronis R Pacing Leads and Lead Adaptors are used in cardiac pacing systems to ensure proper electrical conduction to the heart. They are primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K933055 ↗
Decision Date
May 2, 1994
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on May 2, 1994. Manufactured by Medtronic Vascular, it is classified as a Class III device under product code DTB.
What It Is
The Medtronis R Pacing Leads and Lead Adaptors are components of cardiac pacing systems. These leads are designed to transmit electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The adaptors facilitate compatibility between different lead and pacemaker systems, enhancing the versatility and utility of cardiac pacing interventions.
Clinical Applications
These devices are commonly used in procedures involving the implantation of pacemakers, particularly in patients with arrhythmias or heart block. Cardiologists and electrophysiologists typically use them in hospital settings, including operating rooms and cardiac catheterization labs. They are vital for patients requiring long-term cardiac rhythm management.
Indications for Use
The FDA indications suggest that these devices are intended for patients who need cardiac pacing due to conditions like bradycardia or heart block. They are suitable for individuals who require a reliable means of maintaining heart rhythm.
Practical Considerations
When using these leads and adaptors, clinicians should consider the compatibility with existing pacemaker systems. Proper sizing and placement are crucial for optimal performance. Familiarity with the specific technique for lead insertion and adaptor connection is essential for successful implantation.
Frequently Asked Questions
What is Medtronis R Pacing Leads and Lead Adaptors used for?
They are used to transmit electrical impulses from a pacemaker to the heart, ensuring proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in hospital settings.
What are the FDA-cleared indications?
They are indicated for patients needing cardiac pacing due to conditions like 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.