đź“‹ FDA Reference
Permanent Lead Intraducer
Daig
Summary: The permanent lead introducer by Daig is a medical device used to facilitate the placement of leads in procedures such as cardiac pacing. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K791129 ↗
Decision Date ?
July 17, 1979
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The permanent lead introducer by Daig was cleared through the FDA 510(k) pathway on July 17, 1979. It is classified as a Class 2 device under product code DYB.
What It Is
The permanent lead introducer is a specialized medical device designed to aid in the insertion of leads, such as those used in cardiac pacemakers or defibrillators. It typically consists of a sheath and dilator system that allows for the smooth passage of leads through the vascular system to the heart. This device is crucial in ensuring accurate lead placement, minimizing trauma to the vessel, and reducing the risk of complications.
FDA-Cleared Indications
- Facilitation of the placement of permanent cardiac leads.
- Use during implantation procedures for cardiac pacemaker or defibrillator leads, according to the device labeling.
Clinical Applications
- Introducing permanent pacemaker leads through a central vein toward the heart.
- Introducing implantable cardioverter-defibrillator leads during device implantation.
- Providing vascular access and support for lead advancement in cardiac electrophysiology procedures.
Practical Considerations
- The introducer size must match the selected lead and the patient's venous anatomy.
- Confirm compatibility with the lead system and other components before use.
- Use fluoroscopic or other appropriate imaging guidance and sterile technique during insertion.
- Insertion technique should minimize venous trauma, bleeding, thrombosis and risk of pneumothorax when central venous access is used.
- MRI safety is not established from the available record. MRI conditions should be confirmed in the device labeling; the implanted pacemaker or defibrillator system must also be evaluated separately.
Frequently Asked Questions
What is the permanent lead introducer used for?
It is used to facilitate the placement of cardiac leads during procedures like pacemaker or defibrillator implantation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings, particularly in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring the implantation of cardiac leads, such as those needing pacemakers or 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.