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implantable tined trans pacing lead revis label
Medtronic Vascular
Summary: The implantable tined trans pacing lead by Medtronic Vascular is used in cardiac pacing procedures. It is typically utilized by cardiologists for patients requiring temporary or permanent pacing.
FDA Clearance Information
Pathway
510K
Number
K871333 ↗
Decision Date
May 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on May 6, 1987. Manufactured by Medtronic Vascular, it is classified as a Class III device under product code DTB.
What It Is
The implantable tined trans pacing lead is a medical device designed for cardiac pacing. It features tines that help secure the lead in place within the heart, ensuring stable electrical conduction. This device is crucial for patients with arrhythmias who require consistent cardiac pacing to maintain heart rhythm.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology labs and during cardiac surgery. It is essential for patients with bradycardia or heart block who need temporary or permanent pacing. The device is often used in both hospital settings and specialized cardiac centers.
Indications for Use
The device is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is suitable for those needing either temporary or permanent pacing solutions.
Practical Considerations
The lead is typically available in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemakers and requires careful placement to ensure optimal performance. Clinicians should be trained in lead placement techniques to minimize complications.
Frequently Asked Questions
What is the implantable tined trans pacing lead used for?
It is used for cardiac pacing in patients with arrhythmias, such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, use this device.
What are the FDA-cleared indications?
The device is 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.