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endocardial pacing leads-anchoring sleeve modified
Medtronic Vascular
Summary: The endocardial pacing leads-anchoring sleeve by Medtronic Vascular is a device used in cardiac pacing procedures to secure pacing leads within the heart. It is primarily used by cardiologists and cardiac surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K884005 ↗
Decision Date
December 5, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial pacing leads-anchoring sleeve by Medtronic Vascular was cleared through the FDA 510(k) pathway on December 5, 1988. It is classified as a Class III device under product code DTB.
What It Is
This device is an anchoring sleeve used in conjunction with endocardial pacing leads. It functions to secure the leads in place within the heart, ensuring stable electrical conduction for pacing. The sleeve is typically made of biocompatible materials that allow for secure fixation without causing damage to cardiac tissue.
Clinical Applications
Commonly used in cardiac pacing procedures, this device is essential in ensuring the stability of pacing leads in patients requiring pacemakers. It is used in electrophysiology labs and cardiac surgery suites, primarily by cardiologists and cardiac surgeons. The device is suitable for a wide range of patients, including those with arrhythmias or heart block requiring pacemaker implantation.
Indications for Use
The device is indicated for use in patients who require stable placement of endocardial pacing leads. This includes individuals with conditions such as bradycardia or heart block where consistent cardiac pacing is necessary.
Practical Considerations
When using this device, clinicians should consider the appropriate sizing to match the pacing leads and ensure compatibility with the specific pacemaker system in use. Proper technique in securing the sleeve is crucial to prevent lead dislodgement.
Frequently Asked Questions
What is endocardial pacing leads-anchoring sleeve used for?
It is used to secure pacing leads within the heart during pacemaker implantation procedures.
What specialties typically use this device?
Cardiology and cardiac surgery specialties typically use this device.
What are the FDA-cleared indications?
The device is indicated for stabilizing endocardial pacing leads in patients requiring pacemakers.
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.