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model 366-14 intermedics lead connector cap
Intermedics
Summary: The Model 366-14 Intermedics Lead Connector Cap is a medical device used to secure and insulate the ends of pacemaker leads. It is primarily used by cardiologists during pacemaker implantation or replacement procedures.
FDA Clearance Information
Pathway
510K
Number
K864738 ↗
Decision Date
January 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 366-14 Intermedics Lead Connector Cap was cleared through the FDA 510(k) pathway on January 6, 1987. It is manufactured by Intermedics and classified as a Class III device.
What It Is
The Model 366-14 Intermedics Lead Connector Cap is designed to secure and insulate the ends of pacemaker leads that are not connected to a pulse generator. This device ensures electrical isolation and protection of the lead ends, preventing potential electrical hazards or tissue damage. It is typically used in procedures involving pacemaker implantation, replacement, or lead management.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and during surgical procedures involving pacemakers. It is used by cardiologists and cardiac surgeons to manage pacemaker leads that are temporarily or permanently not connected to a pulse generator. The device is essential in maintaining the integrity and safety of the pacemaker system, especially in patients undergoing device upgrades or lead revisions.
Indications for Use
The FDA indications for this device involve its use in securing and insulating pacemaker leads. It is intended for patients who have pacemaker leads that need to be managed safely, either during initial implantation, replacement, or when leads are not in use but remain in the body.
Practical Considerations
The Model 366-14 Intermedics Lead Connector Cap is typically compatible with a range of pacemaker leads. Clinicians should ensure proper sizing and secure attachment to prevent dislodgement. It is important to follow aseptic techniques during application to prevent infection.
Frequently Asked Questions
What is the Model 366-14 Intermedics Lead Connector Cap used for?
It is used to secure and insulate the ends of pacemaker leads that are not connected to a pulse generator.
What specialties typically use this device?
Cardiologists and cardiac surgeons, particularly those specializing in electrophysiology and pacemaker management, use this device.
What are the FDA-cleared indications?
The device is indicated for securing and insulating pacemaker leads, ensuring electrical isolation and protection of the lead ends.
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.