📋 FDA Reference
Endocard Pacin Lead-Std Length PL100
Daig
Summary: The Endocard Pacing Lead-Std Length PL100 by Daig is a cardiac pacing lead used in patients requiring cardiac rhythm management. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K771564 ↗
Decision Date ?
September 14, 1977
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Endocard Pacing Lead-Std Length PL100 was cleared by the FDA through the 510(k) pathway on September 14, 1977. Manufactured by Daig, it is classified as a Class III device under product code DTB.
What It Is
The Endocard Pacing Lead-Std Length PL100 is a medical device designed for cardiac pacing. It is a flexible wire that connects a pacemaker to the heart, delivering electrical impulses to maintain an adequate heart rate. This device is crucial for patients with arrhythmias or heart block, ensuring proper cardiac function.
FDA-Cleared Indications
- Use as a lead component of an implanted cardiac pacemaker system when cardiac pacing is clinically indicated.
- Use to deliver electrical stimulation to the heart in patients requiring treatment for inadequate or abnormal heart rates, including bradycardia or heart block.
Clinical Applications
- Transvenous pacemaker implantation for patients requiring cardiac pacing.
- Connection of an implanted pacemaker generator to the heart for delivery of pacing impulses.
- Cardiac rhythm management in patients with clinically significant slow heart rates or conduction block.
Practical Considerations
- The standard-length lead must be appropriate for the patient's anatomy and the planned route from the venous access site to the heart.
- The lead must be compatible with the selected pacemaker generator and connector system.
- Implantation requires fluoroscopic or other appropriate imaging guidance and should be performed by clinicians trained in pacemaker implantation.
- MRI safety cannot be determined from this historical device record alone; the complete implanted system, including the generator and lead, must be evaluated according to current labeling.
- Potential complications include lead dislodgment, failure to capture or sense, venous injury, infection, bleeding, arrhythmia, and cardiac perforation.
Frequently Asked Questions
What is Endocard Pacing Lead-Std Length PL100 used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to slow heart rhythms or heart block.
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.