📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use with implantable cardiac devices to cover and insulate DF-1 lead terminals.
- Use when a DF-1 lead terminal is not connected to an active device port and requires protection from electrical contact.
Clinical Applications
- Capping an unused DF-1 terminal during pacemaker implantation or revision.
- Capping an unused DF-1 terminal during implantable cardioverter-defibrillator implantation or revision.
- Insulating and protecting a disconnected DF-1 lead terminal when a lead is retained in place.
- Maintaining electrical isolation of a DF-1 lead terminal within a cardiac implant system.
Practical Considerations
- Confirm that the cap is compatible with the specific DF-1 lead terminal and implantable cardiac device system.
- Use the correct cap size and seat it securely according to the device labeling and procedural technique.
- Inspect the terminal and cap for damage before use; improper placement may cause inadequate insulation or electrical contact.
- The provided record does not establish MRI safety. Verify the complete implanted system and current manufacturer labeling before MRI.
- This device is intended for use by trained cardiac electrophysiology or cardiothoracic personnel; contraindications and warnings should be checked in the official labeling.
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.