📋 FDA Reference
Changes to Encor Pervenous J-Atrial Leads
Cordis Leads
Summary: The Encor Pervenous J-Atrial Leads are used in cardiac pacing systems to facilitate electrical conduction in patients with arrhythmias. They are typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K873772 ↗
Decision Date ?
October 19, 1988
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Encor Pervenous J-Atrial Leads were cleared through the FDA 510k pathway on October 19, 1988. Manufactured by Cordis Leads, this device is classified as Class III under product code DTB.
What It Is
The Encor Pervenous J-Atrial Leads are specialized cardiac leads designed for use in pacing systems. These leads are inserted into the heart's atrium via the venous system to provide electrical stimulation for patients with arrhythmias. They are critical components in maintaining proper heart rhythm and are often used in conjunction with pacemakers.
FDA-Cleared Indications
- Use as a component of a cardiac pacing system when atrial electrical stimulation is indicated.
- Placement through the venous system for transvenous pacing of the atrium.
- Use in accordance with the labeling of the compatible pacemaker or pacing system.
Clinical Applications
- Transvenous placement of an atrial pacing lead during pacemaker implantation.
- Delivery of electrical stimulation to the right atrium as part of a cardiac pacing system.
- Long-term atrial pacing when prescribed by a cardiologist or electrophysiologist.
Practical Considerations
- The lead length and configuration must match the patient's anatomy and the selected pacing system.
- Confirm electrical, connector and mechanical compatibility with the intended pacemaker or pulse generator before implantation.
- Placement requires venous access and fluoroscopic or other appropriate imaging guidance by trained cardiac device specialists.
- The record provided does not establish MRI-conditional labeling; MRI eligibility should be confirmed from the specific lead and complete pacing-system labeling.
- Potential complications include infection, bleeding, venous thrombosis, lead dislodgement, cardiac perforation, pneumothorax and pacing or sensing failure.
Frequently Asked Questions
What is Encor Pervenous J-Atrial Leads used for?
They are used to provide electrical conduction in cardiac pacing systems for patients with atrial arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients needing electrical conduction support due to atrial arrhythmias.
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.