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Cordis Permanent Pervenous Cardiac Leads
Summary: Cordis Permanent Pervenous Cardiac Leads are used in cardiac pacing systems to deliver electrical impulses to the heart. Primarily used by cardiologists, these leads are crucial in managing patients with arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K791768 ↗
Decision Date ?
November 5, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Cordis Permanent Pervenous Cardiac Leads were cleared through the FDA 510(k) pathway on November 5, 1979. Manufactured by Cordis, this device is classified as Class 3 under product code DTB.
What It Is
Cordis Permanent Pervenous Cardiac Leads are medical devices designed to be implanted into the heart's venous system to provide electrical stimulation for cardiac pacing. These leads are integral components of pacemaker systems, ensuring the heart maintains an adequate rhythm. The leads are typically inserted through a vein and positioned in the heart to deliver electrical impulses effectively.
FDA-Cleared Indications
- Permanent cardiac pacing for patients with bradycardia.
- Permanent cardiac pacing for patients with heart block.
- Use as an implanted lead component of a permanent pacemaker system.
Clinical Applications
- Transvenous implantation of a permanent pacemaker lead through a vein into the heart.
- Delivery of electrical pacing impulses to maintain an adequate heart rate.
- Cardiac pacing in patients with clinically significant slow heart rhythms.
- Cardiac pacing in patients with conduction disorders such as heart block.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and the intended pacing configuration.
- Implantation requires venous access and imaging or electrical testing to confirm appropriate lead position and function.
- Potential complications include lead dislodgement, venous injury or perforation, infection, thrombosis, and lead malfunction.
- MRI safety depends on the specific lead, pacemaker generator, and complete implanted system. The device should not be considered MRI-conditional unless the applicable labeling confirms it.
- Contraindications and precautions depend on the patient's condition, venous anatomy, infection risk, and the specific pacemaker system being used.
Frequently Asked Questions
What is Cordis Permanent Pervenous Cardiac Leads used for?
These leads are used for delivering electrical impulses to the heart in patients requiring permanent cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in the management of arrhythmias.
What are the FDA-cleared indications?
The leads are indicated for patients needing permanent cardiac pacing, such as those with bradycardia 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.