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df-1 terminal cap
Pacesetter
Summary: The DF-1 Terminal Cap by Pacesetter is a medical device used in conjunction with implantable cardiac devices. It is typically utilized by cardiologists and electrophysiologists to ensure secure electrical connections.
FDA Clearance Information
Pathway
510K
Number
K954551 ↗
Decision Date
December 26, 1995
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The DF-1 Terminal Cap was cleared through the FDA 510(k) pathway on December 26, 1995, by Pacesetter. It is classified as a Class III device under product code DTB.
What It Is
The DF-1 Terminal Cap is a component used in implantable cardiac devices, such as pacemakers and defibrillators. It serves to protect and insulate the terminal ends of leads, ensuring reliable electrical connections. This device is crucial for maintaining the functionality and safety of cardiac implants.
Clinical Applications
The DF-1 Terminal Cap is commonly used in cardiac electrophysiology and cardiothoracic surgery settings. It is essential during the implantation of pacemakers and defibrillators, where it helps secure lead connections. This device is particularly relevant for patients requiring long-term cardiac rhythm management.
Indications for Use
The DF-1 Terminal Cap is indicated for use in patients who require implantable cardiac devices. It is specifically designed to ensure secure and insulated connections of the device leads, which is critical for the effective functioning of pacemakers and defibrillators.
Practical Considerations
The DF-1 Terminal Cap is compatible with standard DF-1 leads used in cardiac devices. Clinicians should ensure proper sizing and secure attachment to prevent lead dislodgement. Familiarity with the device's compatibility with various implantable systems is essential for optimal use.
Frequently Asked Questions
What is DF-1 Terminal Cap used for?
It is used to protect and insulate the terminal ends of leads in implantable cardiac devices, ensuring secure electrical connections.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
The device is indicated for ensuring secure and insulated connections of leads in implantable cardiac devices like pacemakers and defibrillators.
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.